Managing Economically Motivated Adulteration Joseph Scimeca Ph D

Agenda • GMA Economic Adulteration WG • GFSI Food Fraud Prevention • Why FSMA

GMA Economic Adulteration WG • Initially formed in Dec 2008 • Identified WG Priorities:

GMA EA WG – Awareness/Education • Published AT Kearney/GMA Science Education Foundation Report in

GFSI – Food Fraud 6 Managing Economically Motivated Adulteration – April 2015 © 2014

Food Fraud Think Tank New concept for GFSI 2015 2014 2013 2012 7 Managing

GFSI Position Incorporation of new key elements in Guidance Document • Cascade to food

Key Elements Food Fraud Prevention GFSI Foodfor. Fraud Requirements Clause Name Requirement Food Fraud

Food Fraud Prevention Vulnerability Assessments Vulnerability Control Plan 10 • Supply Chain Mapping •

Implementation of Food Fraud Mitigation GFSI Food Fraud Strategic Plan Incorporation in GFSI Guidance

PAS 96: 2014 • Provides guidance on approaches and procedures to improve resilience to

FSMA Things that might have seemed like just a good idea before, are now

FSMA - Intentional Adulteration • In the re-proposed regulations for preventive controls, the hazard

Designing a Food Fraud Protection Plan 15 Managing Economically Motivated Adulteration – April 2015

Three questions can help inform your company's economic adulteration strategy Do you understand your

Key Elements of Food Fraud Protection Food Fraud Policy Food Fraud Prevention System FF

EMA Vulnerability Assessment Tool GOAL: Develop a tool similar to “Carver + Shock” to

GMA EA WG – Designing the blueprint Integrate information into EMA Vulnerability Assessment Tool

EMA Vulnerability Assessment Tool GMA EA WG Activities • Design blueprint for EMA Vulnerability

Example Visual of Tool 22 Managing Economically Motivated Adulteration – April 2015 © 2014

GFSI Position -Future Integral Part of FSMS An Integrated Food Safety Food Defence Prevention

Key Takeaways • Need to develop EMA Protection Plan • Gain visibility of supply

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

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Managing Economically Motivated Adulteration Joseph Scimeca, Ph. D VP, Global Regulatory & Scientific Affairs Corporate Food Safety, Quality and Regulatory GMA Science Forum April, 2015 Managing Economically Motivated Adulteration – April 2015 www. cargill. com 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. © 2014 Cargill, Incorporated. All rights reserved.

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

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

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

CONSUMER PRODUCT FRAUD: DETERRENCE AND DETECTION Strengthening Collaboration to Advance Brand Integrity and Product Safety 2010 In Association With in association with 5 Managing Economically Motivated Adulteration – April 2015 © 2014 Cargill, Incorporated. All rights reserved.

GFSI Position Incorporation of new key elements in Guidance Document • Cascade to food safety management schemes via benchmarking process • Incorporation in company’s food safety management system Many ongoing initiatives on food fraud • Leading role for GFSI • Direction & Alignment Schemes and companies need time for this new challenge ‘GFSI Position Paper’ issued in 2014, followed by Incorporation in ‘Version 7’ in early 2016 Managing Economically Motivated Adulteration – April 2015 © 2014 Cargill, Incorporated. All rights reserved.

Key Elements Food Fraud Prevention GFSI Foodfor. Fraud Requirements Clause Name Requirement 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. Managing Economically Motivated Adulteration – April 2015 © 2014 Cargill, Incorporated. All rights reserved.

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

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

PAS 96: 2014 • 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) 12 Managing Economically Motivated Adulteration – April 2015 © 2014 Cargill, Incorporated. All rights reserved.

FSMA 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 13 Managing Economically Motivated Adulteration – April 2015 © 2014 Cargill, Incorporated. All rights reserved.

FSMA - Intentional Adulteration • 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 14 Managing Economically Motivated Adulteration – April 2015 © 2014 Cargill, Incorporated. All rights reserved.

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

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

EMA Vulnerability Assessment Tool GOAL: Develop a tool similar to “Carver + Shock” to quantitatively assess vulnerability of supply chains to EMA 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 18 Managing Economically Motivated Adulteration – April 2015 © 2014 Cargill, Incorporated. All rights reserved.

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

GMA EA WG – Designing the blueprint 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 20 Managing Economically Motivated Adulteration – April 2015 © 2014 Cargill, Incorporated. All rights reserved.

EMA Vulnerability Assessment Tool 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 Managing Economically Motivated Adulteration – April 2015 © 2014 Cargill, Incorporated. All rights reserved.

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

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