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The current state of food fraud prevention: overview and requirements to address ‘How to Start?’ and ‘How Much is Enough?’
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ScienceDirect The current state of food fraud prevention: overview and requirements to address ‘How to Start?’ and ‘How Much is Enough?’ John W Spink Food Fraud – intentional deception for economic gain using food – is one of the most urgent and active food research and regulatory areas. The current state of research has expanded to include criminology, public policy, business enterprise risk management, and implementation of a management system. This range of disciplines has been critical since the hazard analy urgent and active food research and regulatory areas. The current state of research has expanded to include criminology, public policy, business enterprise risk management, and implementation of a management system. This range of disciplines has been critical since the hazard analysis, and prevention strategies are fundamentally different when addressing an intelligent human adversary. The broad range of literature has been adopted or adapted to Food Fraud prevention including the identification of the next set of urgent questions: ‘How much is enough?’ and ‘How to start?’ A summary of the literature was provided with a summary of seven questions, two concepts, seven critical steps, and one decision. The seven questions provide a gap analysis to calibrate how much has been completed and how much is still to be done. The two concepts are policy level framing questions for the next activity. The seven steps are for a Food Fraud Task Force that uses the previous insight to create a Food Fraud Prevention Strategy proposal including resource-allocation and key task identification. Finally, the ‘One Decision’ is an official acceptance of the proposed strategy and the ongoing monitoring of the successful and thorough implementation of the management system. This overall method is referred to as the Food Fraud Implementation Method (FFIM). Address Michigan State University, 1124 Farm Lane Road, East Lansing, MI, 48824, USA Corresponding author: Spink, John W ([email protected])
Current Opinion in Food Science 2018, 24:xx–yy This review comes from a themed issue on Food safety
Introduction Food Fraud is one of the most urgent and active food industry topics. While there is evidence of Food Fraud incidents from ancient times and is mentioned in early Chinese writings [1], only in the last few years has the focus shifted from reaction to prevention. The prevention foundation has expanded to include: root cause analysis based in Behavioral Science and Social Science; focused opportunity-reducing measures in Criminology; decisionmaking methods in Public Policy for governments and Enterprise Risk Management (ERM) for industry; Information Technology and Managerial Accounting for monitoring Supply Chain Management and traceability for the flow of product; and an expanded focus on Food Science regarding authenticity confirmation. During this research expansion, there has been ongoing development or re-application of laws, regulations, standards, certifications, and business practices. The research justification of this paper is to review the current state including a very clear explanation of the requirements and then provide several concepts and steps for an enterprise – whether a company, country, NGO, association, or supplier – to strategically and methodically address the problem.
Background Because of an increased consumer and government awareness of food fraud, there is an increased awareness of the public health vulnerability and more significant economic impact of an incident. The increased focus has led to food fraud-specific compliance requirements beyond governments to private certifications and standards. Since food fraud is a root cause of some food safety incidents, a proactive approach will reduce the overall public health and economic risks. The foundational concepts of the food fraud definition and requirements will be covered in more detail before addressing ‘How to start?’ and ‘How much is enough?’
Edited by Lawrence Goodridge and John O’Brien
Food fraud defined
2214-7993/ã 2019 Elsevier Ltd. All rights reserved. 2214-7993/ã 2019 Elsevier Ltd. All rights reserved.
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Food Fraud is widely and generally regarded as intentional deception for economic gain using food [2–16]. The types of food fraud include: adulterant-substances (dilution, substitution, concealment, and unapproved enhancements), mislabelling, gray market/diversion, smuggling, theft, and intellectual property rights counterfeiting (Table 1) [2]. A term related to Food Fraud is economically motivated
Current Opinion in Food Science 2019, 24:1–9
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Table 1 Food fraud types, definitions, and examples (as published by GFSI [26] which references [2,4,25,30,32,34] GFSI (1) type of food fraud
Definition from SSAFE (2)
Examples from GFSI FFTT (3)
General type of food fraud
Dilution
The process of mixing a liquid ingredient with high value with a liquid of lower value.
Adulterantsubstance (adulterant)
Substitution
The process of replacing an ingredient or part of the product of high value with another ingredient or part of the product of lower value. The process of hiding the low quality of a food ingredients or product.
Watered down products using nonpotable/unsafe water Olive oil diluted with potentially toxic tea tree oil Sunflower oil partially substituted with mineral oil Hydrolyzed leather protein in milk Poultry injected with hormones to conceal disease Harmful food colouring applied to fresh fruit to cover defects Melamine added to enhance protein value Use of unauthorized additives (Sudan dyes in spices)
Adulterantsubstance or tampering
Expiry, provenance (unsafe origin) Toxic Japanese star anise labeled as Chinese star anise Mislabeled recycled cooking oil Sale of excess unreported product Product allocated for the US market appearing in another country Copies of popular foods not produced with acceptable safety assurances Counterfeit chocolate bars
Tampering
Concealment
Unapproved enhancements
Mislabelling
The process of adding unknown and undeclared materials to food products in order to enhance their quality attributes. The process of placing false claims on packaging for economic gain.
Grey market production/theft/diversion
Outside scope of SSAFE tool.
Counterfeiting/intellectual property rights
The process of copying the brand name, packaging concept, recipe, processing method, and so on. of food products for economic gain.
Adulterantsubstance or tampering
Adulterantsubstance or tampering
Overrun, theft, or diversion (5) Counterfeiting
Notes: (1) GFSI — Global Food Safety Initiative. (2) SSAFE — Safe Secure and Affordable Food for Everyone. (3) GFSI FFTT — Global Food Safety Initiative: Food Fraud Think Tank. (4): Gray Market — a market employing irregular but not illegal methods; Theft — something stolen. (5): Diversion/ Parallel Trade — the act or an instance of diverting straying from a course, activity, or use. Comment: This table is used as the types of fraud list and definitions in the GFSI Food Fraud Technical Document published in 2018. That report is a reference for GFSI compliance.
adulteration (EMA) where the U.S. Food and Drug Administration’s working definition requires a ‘substance’ that is added or deleted for ‘economic gain’ [17]. This definition of EMA is equivalent to an ‘adulterant-substance’ type of Food Fraud. The types of products include: raw materials, incoming goods, goods in manufacturing, goods in storage, products at retailers, and also through consumption to the destruction of food and food packaging. Also, to address what is the role of industry in food fraud prevention it is important to review the types of industry stakeholders: Industry is defined as: producers, manufacturers, food distributors, retailers, academics/strategy researchers, technology suppliers including authenticity affirmation (e.g. test, transaction analysis, or external component), data management, investigator, auditor, market monitors, and others. Food Fraud is one of the four food risks that include Food Quality, Food Safety, Food Fraud, and Food Defense. From Codex Alimentarius, Food Quality is ‘all the attributes that influence a product’s value to the consumer . . . . and positive attributes such as the origin, colour, flavour, Current Opinion in Food Science 2019, 24:1–9
texture and processing method of the food’ [18]. Generally, this is meeting the specification of the buyer or consumer. Also from Codex Alimentarius, Food Safety is the set of activities that lead to ‘assurance that food will not cause harm to the consumer when prepared and/or eaten according to its intended use’ [18]. Food Defense is defined as programs created to protect against an intentional act with the objective to cause harm such as psychological terror, economic harm, or a public health threat [5,26]. It is important to note that the US Food Safety Modernization Act—Intentional Adulteration Final Rule narrows the focus to ‘wide-scale human health harms’ [19]. To note, a related but different term is Food Security which is defined by the World Health Organization as enough food calories, better food nutrition, and then to increase prosperity for the individuals and the society in general [24]. The Food Risk Matrix presents the relationship between Food Fraud, Food Quality, Food Safety, and Food Defense segmented by the basic action and motivation of the problem (Figure 1) [2]: www.sciencedirect.com
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Food fraud overview FFIM Spink 3
Figure 1
Food
Motivation
Food
Gain:
Quality Food
Fraud Food
Economic Harm:
Safety
Defense
Unintentional
Intentional
Public Health, Economic, or Terror
Action Current Opinion in Food Science
The food risk matrix [2].
Food fraud prevention: applying criminology to the human adversary
It has been said, ‘if the biological organism in question was a microbe you would apply the discipline of microbiology; for food fraud, the biological organism in question is a human so naturally, you would apply the Social Sciences and Criminology’ [1]. A major shift in addressing Food Fraud was to apply Criminology theory to both understand the root cause and – more importantly – understand how to reduce the factors or vulnerabilities that enable the problem to occur in the first place. When beginning to address an emerging issue such as Food Fraud, Criminology theory refers to a problem which is ‘ . . . the basic unit of police work rather than a crime, a case, calls, or incidents’ [20]. ‘A problem is something that concerns or causes harm to citizens, not just the police. [ . . . ] Addressing problems means more than quick fixes: it means dealing with conditions that create problems’ [20]. Food Fraud fits the Criminology classification of a ‘complex problem’ that is most efficiently addressed by opportunity reducing measures – rather than pursuing and apprehending the perpetrators – that control the space where crime occurs. The criminology focus of Situational Crime Prevention is more on reducing the temptations of the physical space rather than a study of the criminals, themselves. When considering the food fraud ‘problems,’ there is so much variation in the target, criminal, and type of criminal opportunity, it is most efficient to focus on reducing the opportunity. While it is essential to pursue and prosecute food fraudsters who are caught ‘as we will never test our way to food safety, we will not arrest our way to safety.’ The goal is not to catch food fraud but to prevent it from occurring in the first place. Applying Environmental Criminology, and more specifically Situational Crime Prevention, provides resources to www.sciencedirect.com
understand the root cause of the problem, select countermeasures and controls systems, and conduct ongoing monitoring. The Criminology-based SARA Model (Scanning, Analysis, Response, and Assessment) is a continuous improvement cycle akin to quality management ‘plan-do-check-act’ tools and other risk management systems [20]. Situational Crime Prevention theory is defined as ‘opportunity-reducing measures that are directed at highly specific forms of crime, involve management, design, or manipulation of the immediate environment in as a systematic and permanent way as possible, and make crime more difficult or risky, or less rewarding and excusable as judged by a wide range of offenders’ [21]. This is founded on several other Criminology theories including Rational Choice Theory and Routine Activities Theory. The Rational Choice Theory considers that criminals believe they can successfully and profitably complete the criminal act therefore they choose to commit a crime. The Routine Activities Theory suggests that criminals often find opportunities for committing crimes during their regular daily activities. These theories are combined in another Criminology analytical tool—the Crime Triangle. Here a victim, a fraudster, and a guardian or hurdle gap are the three required components to enable a ‘motivated offender’ and dimension the fraud opportunity (Figure 2) [20].
Enterprise risk management/COSO The Sarbanes-Oxley Act of 2002 (SOX or Sarbox) is a requirement for all public companies that operate in the U.S. that include companies listed on the New York Stock Exchange [29]. To meet this U.S. regulatory requirement, five of the leading financial and managerial accounting associations built upon previous work by the Committee of the Sponsoring Organizations of the Treadway Commission (COSO). The Treadway Commission, itself, was previously created in 1985 by the National Commission on Fraudulent Financial Reporting which is referred to as The Treadway Commission after the first Chairman, James C. Treadway. The activity expanded in 2004 when the Enterprise Risk Management frame was created and Figure 2
Guardian & Hurdle Gaps
VicƟm Fraud Opportunity Fraudster Current Opinion in Food Science
The crime triangle including victim, fraudster, and guardian and hurdle gaps [35]. Current Opinion in Food Science 2019, 24:1–9
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then expanded in 2017 with the publication of ‘Enterprise Risk Management—Integrating with Strategy and Performance,’ which highlights the importance of considering risk in both the strategy-setting process and in driving performance’ [29]. The motivation for creating COSO, and expanding the ERM concept in 2009 and 2017, was ‘in response to senior executives’ need for effective ways to better control their enterprises and to help ensure that organizational objectives related to operations, reporting, and compliance are achieved’ [29]. Enterprise Risk Management (ERM) is a structured approach to managing risk across an organization that could be a company, government, or any entity. The key concepts are that all risks across an enterprise should be calibrated and coordinated with all other risks. There is a common ‘risk threshold’ that should be managed through Internal Controls (a common set of practices and procedures) and an Integrated Framework (a way to calibrate and coordinate interdisciplinary activities). From COSO/ERM: ‘Internal controls: A process, effected by an entity’s board of directors, management and other personnel, designed to provide reasonable assurance regarding the achievement of objectives in the following categories: effective and efficiency of operations, reliability in financial reporting, and compliance with applicable laws and regulations. An internal control system is a synonym for internal controls applied in an entity’ [42]. ‘Integrated frameworks: Are defined as interconnectivity of internal controls to coordinate operations as well as provide an overall monitoring and calibrating system’ [42].
Sarbanes–Oxley requires the Board of Directors – including the CEO/CFO and the corporate auditor – to sign a legal regulatory document confirming that the Corporate Annual Report confirms all risk is within the threshold or disclosed (see publicly disclosed 10-Q and 10-K reports). While this is a U.S. requirement, often there are similar requirements found in other countries [29]. Non-U.S. and private companies who are not subject to these SOX laws commonly require a similar – if not identical – Internal Control and Integrated Framework. COSO noted that ‘This framework has become the most widely used internal control framework in the U.S. and has been adapted or adopted by numerous countries and businesses around the world’ [29]. It is important to note that food safety and operational employees of food companies are often not aware that their quality control activities support these corporate-level regulatory requirements. Such requirements are commonly supported and documented through COSO/ERM methods and tools. Current Opinion in Food Science 2019, 24:1–9
Since COSO/ERM is a widely adopted system, there is extensive education, training, certification, and auditing. One Food Fraud related COSO/ERM focus is in the process step of Risk Assessment. Within risk assessment, there is a discipline to identify new or emerging problems. COSO prescribes a method for assessments [29]: ‘Assessing risks consists of assigning values to each risk and opportunity using the defined criteria. This may be accomplished in two stages where an initial screening of the risks is performed using qualitative techniques followed by a more quantitative analysis [detailed assessment] of the most important risks’ [29].
Compliance requirements
Food Fraud is usually already illegal under one law or another—whether food safety, misbranding, mislabeling, consumer fraud, smuggling, intellectual property rights, or related criminal acts such as theft. That said, Food Fraud is usually not holistically addressed by a single law or even a single agency [36]. This was concluded in the U.S. Congressional Research Service’s report on ‘Food Fraud and Economically Motivated Adulteration.’ It notes, ‘ . . . that Congress has not addressed food fraud in a comprehensive manner’ [6]. Specifically, ‘no single federal agency or US law directly addresses Food Fraud.’ In the U.S. the primary food-related public health agency is the U.S. Food and Drug Administration. It prioritizes health hazards while emphasizing all types of Food Fraud has been illegal since at least 1938 when the Food, Drug and Cosmetics Act (FDCA) was published. This act includes sections on ‘Adulterated Foods’ and also a separate section on ‘Misbranded Foods’ [22]. Building upon the FDCA, a major update of US Food Laws occurred within the implementation of the Food Safety Modernization Act of 2011 (FSMA). Further, while not specifically mentioned by name, conducting a Food Fraud Vulnerability Assessment for all types of fraud and for all products is explicitly a requirement of the Food Safety Modernization Act [22,23]: 21 CFR 117.130 and 507.33 Hazard Analysis [22]: “(a) (1) you must conduct a hazard analysis to identify and evaluate . . . known or reasonably foreseeable hazards . . . ” “(2) The hazard analysis must be written regardless of its outcome.” “(iii) The hazard may be intentionally introduced for purposes of economic gain.” Another important consideration is the industry standards that are often a requirement for conducting business. One of the most widely adopted private standards is based on the Global Food Safety Initiative (GFSI) Benchmarking Document [5]. GFSI was created by the 300+ global www.sciencedirect.com
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Food fraud overview FFIM Spink 5
corporate members of the Consumer Goods Forum (CGF) to harmonize and standardize the industry practices. GFSI is led by some of the world’s largest food manufacturers and retailers who have continued efforts to engage medium, small, and micro-sized companies. The Food Safety standards are created and managed by quality program owners such as BRC, FSSC 22000, IFS, SQF, and others. A food producer, manufacturer, or brand owner company would seek compliance with those food safety standards which, in turn, would seek GFSI endorsement—thus, the reference to a ‘GFSI compliance standard.’ Reportedly over 65% of the world food trade is conducted by members of GFSI and compliance is critical for companies to be able to conduct commerce. Many of those members are at the end of the supply chain – such as retailers and manufacturers – so their influence is very broad. Many companies have stated there are two paths to becoming a new supplier for them regarding a Food Safety Management System: (1) currently GFSI compliant and (2) soon to be GFSI compliant. As of January 2018, the GSFI Food Safety Management System is required – it is NOT optional – to include: (1) a Food Fraud Vulnerability Assessment that is updated and (2) a Food Fraud Prevention Strategy/Mitigation Plan that is implemented [4]. GFSI requires separate assessments for Food Safety (HACCP), Food Fraud (VACCP) and for Food Defense (TACCP) [25,26]. The three separate assessments must be correlated under the overall Food Safety Management System.
step is framing the question or defining the goal, scope, and objective of the activity.
Framing the question Addressing Food Fraud has broadened the scope of traditional food safety incidents to address all related root causes, the risk assessment for an entire company broadened from known, high-frequency incidents to all related vulnerabilities [38,39]. The focus has been on a proactive vulnerability reduction or elimination of the root causes of problems of the problems. A vulnerability is different from a risk or hazard as mitigation and prevention are unique activities. ‘The US Department of Homeland Security describes vulnerability and risk as follows [27]: Vulnerability. A physical feature or operational attribute that renders an entity open to exploitation or susceptible to a given hazard.’ Risk. The potential for an unwanted outcome resulting from an incident, event, or occurrence, as determined by its likelihood and the associated consequences’ [27]. The management focus is on prevention rather than mitigation [28]: ‘Mitigation: is intended to reduce the consequence of the event.’ ‘Prevention: is intended to reduce or eliminate the likelihood of the event occurring.’
Once the Food Fraud Vulnerability Assessment has been conducted and the Food Fraud Prevention Strategy is created and implemented, there can be an identification of the food fraud vulnerabilities that are above the risk tolerance. Once those specific problems are identified, a Situational Crime Prevention analysis can be conducted to identify where/when/how/why a system weakness has been exploited. Once that ‘hot product’ and ‘hot spot’ [21,22] have been identified, there can be an assessment of the most efficient and effective countermeasures and control systems that will reduce the fraud opportunity. For example, the European Union funded Food Integrity Project (EU FIP) developed a wide range of food authenticity research projects [43,44]. Once the Food Fraud Prevention Strategy is implemented, there can be an evaluation of the efficiency and effectiveness of food authenticity tests [45,46,47].
To clarify, prevention assumes that the root cause of the event could be eliminated or at least greatly reduced in terms of likelihood of occurrence. Also, mitigation assumes the event will frequently occur, so there is a goal to mitigate or reduce the negative consequence.
For a more thorough explanation of a method to manage information and work activities see the research on the Food Fraud Prevention Cycle (FFPC) [37]. To address ‘How much is enough?’ there is a Food Fraud Implementation Method (FFIM) to assess the problem and create an efficient and effective management system. The first
For framing the question of the project scope, for Food Fraud prevention, the concept of an initial screen or prefilter is consistent with concepts such as ISO 31000 Risk Management and has been noted in reports such as by the U.S. Pharmacopeia, SSAFE Organization, PWC/ SSAFE, WUR/ SSAFE, and GFSI [26,30]. One specific
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The Food Fraud regulatory or standards requirements are not very detailed with respect to actual tools or techniques. Conversely for Food Safety and Food Defense, there are quite a bit of detailed and prescriptive assessment approaches such as in the U.S. Food Safety Modernization Act Final Rules for Preventive Controls (Food Safety) and Intentional Adulteration (Food Defense). The financial regulatory and standards requirements provide more details such in the U.S. Sarbanes-Oxley Act of 2002 and the subsequent COSO/Enterprise Risk Management system (COSO/ERM).
Current Opinion in Food Science 2019, 24:1–9
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application is ‘Introducing the Food Fraud Initial Screening Tool (FFIS)’ [31]. The best practice for food fraud risk assessment is to first conduct a quick pre-filter or initial screen but to make sure it covers ALL types of fraud and ALL products. Once this first assessment (the initial screen, FFIS) is completed there can be an identification of where more information is needed or where a more detailed assessment is warranted (the detailed vulnerability assessment, FFVA). Subsequent periodic assessments should then explore vulnerabilities in more detail.
How to start? Address seven questions, two concepts and seven steps
Once the basic concepts are understood, the impost important and often most challenging next step for creating a Food Fraud Prevention Strategy is ‘How to start?’ by following the Food Fraud Implementation Method (FFIM) through ‘7 questions, 2 Concepts and 7 Steps’ [32,33]. The first activity is to conduct a gap analysis to understand how much has been accomplished and how much still needs to be done. The seven questions provide a gap analysis to calibrate how much has been completed and how much is still to be done’ [32,33]. Seven questions Conduct a Food Fraud Vulnerability Assessment (Y/N) Written (Y/N) Implement a Food Fraud Prevention Strategy (Y/N) Written (Y/N) Minimally conduct an annual Food Fraud Incident Review (Y/N) 6 Note: Address all types of Food Fraud (Y/N) 7 Note: Address all products from both incoming goods (e.g. ingredients) and outgoing goods (e.g. finished goods) through to the consumer.’
1 2 3 4 5
The second activity is to establish two basic concepts that set the foundation for future activities. These provide a policy-level framing or foundational starting point for the next, third step. This step helps to evaluate how an organization should specialize in specific food fraud prevention responsibilities and other fraud prevention countermeasures or control systems. This will identify the touch-points between departments and also where there is duplicity such as between corporate security, food safety, and supply chain management. By clearly defining the scope and policy authority there can be guidance on the project management and final implementation. If a clear corporate policy directive is identified and agreed, then a situation is created where a department would violate a corporate policy if they decided to ‘opt-out’ of the activity. Current Opinion in Food Science 2019, 24:1–9
Two basic concepts 1 Concept One—Formally, and specifically, mention food fraud as a ‘food’ issue While this seems simple, there is often confusion as to whether fraud is to be managed by Corporate Security, Supply Chain Management, Purchasing, or corporate functions. By declaring these frauds to be exclusively related to ‘food’, it clearly becomes the domain of food safety and food quality assurance functions. It should be expected that these traditional food safety resources will require corporate assistance from non-traditional resources such as brand protection activities. ‘An example of an agency or company policy statement created is: ‘This statement confirms that AGENCY/ COMPANY expects the food industry to conduct risk or vulnerability assessments, including mitigation or prevention plans where warranted, on all incidents that could lead to a health hazard or the violation of a food law such as the FSMA or the FD&C. This includes all Food Fraud such as adulterant-substances, tampering, theft, illegal diversion or gray markets, illegal mislabeling, and intellectual property rights or product counterfeiting, and others. Consistent with existing Federal and State laws and regulations, third-party certifications play an important role in supporting this type of food supply chain protection’ [33]. 2 Concept Two—Create an enterprise-wide Food Fraud prevention plan After these two concepts are established the third activity is to initiate a project – or referred to here as a task force – that will propose the optimal Food Fraud Prevention Strategy. The seven steps are for a Food Fraud Task Force that uses the previous insight to create a Food Fraud Prevention Strategy proposal including resource-allocation and key task identification. Food fraud task force steps (7 steps) From a business management standpoint, it is most efficient for an executive sponsor to assign this responsibility to a ‘Food Fraud Task Force,’ clearly require addressing these issues below, and then set a due date. The task force is important since a scope that covers all types of fraud and for all products usually is interdisciplinary and involved responsibilities that are distributed across many departments. Once a thorough, holistic, final report is submitted to the executive sponsor, there can be a direct and thorough review of the proposal, identify questions, recommend adjustments, or seek answers to specific questions. This final report can be shared within the enterprise for consideration of compliance, general liability or adjusted human resource needs. The general steps for implementing and managing Food Fraud Prevention include: www.sciencedirect.com
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Food fraud overview FFIM Spink 7
1 Convene a Food Fraud Task Force 2 Create an Enterprise-wide Food Fraud Policy/Mission Statement and begin drafting a Food Fraud Prevention Strategy/Plan 3 Conduct the pre-filter Food Fraud Initial Screening (FFIS) 4 Review additional needs including additional information or a more detailed Food Fraud Vulnerability Assessment (FFVA) 5 Review-specific Food Fraud vulnerabilities in an enterprise risk map (Enterprise Risk Management) 6 Consider countermeasures and control systems to address the ‘very high’ and ‘high’ vulnerabilities 7 Propose a Food Fraud Prevention Strategy including the calibration of the Food Fraud risks on the enterprise risk map A formal report should document all actions and findings for managerial review and oversite. The receipt of the complete and direct task force proposal can lead to requests for specific additional information and informed resource allocation. Of note, a decision to not implement recommendations or implement changes is a decision to accept the status quo. Finally, the fourth activity is the ‘One Decision’ which is an official acceptance of the proposed strategy and the ongoing monitoring of the successful and thorough implementation of the management system. In some situations, ‘no decision’ – no formal acceptance or rejection of the Food Fraud Task Force proposal – is a de facto acceptance of the current state as acceptable. A non-decision by the executive sponsor regarding the proposal could be found in a future audit.
How much is enough? The Food Fraud Implementation Method (FFIM) – including the seven questions, two concepts, seven steps, and one decision – creates an overall management system including the enterprise risk management assessment of the vulnerabilities (for more see Refs. [40,41]). When the results are plotted on a corporate risk map then there is a calibration of the food fraud vulnerabilities in relation to all other enterprise-wide risks. The process creates a clear identification of the vulnerabilities that are above the risk tolerance and then the extent of the countermeasures or control systems that eventually identify ‘How much is enough?’ Identify the vulnerabilities Assess the vulnerabilities using an enterprise-wide scale for likelihood and consequence Rank the vulnerabilities on a risk map in relation to all enterprise-wide risks Identify which vulnerabilities are above the enterprise determined risk tolerance Propose projects that will reduce the vulnerability of the specific problems to within the risk tolerance www.sciencedirect.com
Report that the vulnerabilities are all within the risk tolerance or disclose the non-conformities The implementation of the FFIM – including the activities presented in the FFIS and FFPC – provide a management system to conduct a risk assessment and determine the appropriate risk treatment or the ‘How much is enough?’ question.
Conclusion The Food Fraud research scope has been expanding to include management systems and methods that address implementation. The expansion from ‘what’ is food fraud and ‘severity’ to the practical implementation problem brings up new questions of ‘How to start?’ and ‘How much is enough?’ These new questions require utilizing different disciplines such as criminology, public policy, business enterprise risk management, and then management of the activities. The broadening scope from ‘How to detect fraud?’ to a management system implementation scope creates a shift in focus from the detection of the immediate public health harms to the reducing the overall vulnerability for entire companies or countries. While the disciplines such as criminology and managerial accounting may not be familiar to food scientists yet, they are familiar across a company or country. These disciplines have long-established research and support including training, education, and certification. For those who are new to addressing Food Fraud prevention, there is a thorough and competent body of literature to address ‘how to start?’ and ‘how much is enough?’ The first step is to be confident in taking a holistic and all-encompassing scope with a very light first initial screening. By breaking the complex problem into simple steps, the first steps are logical.
Funding sources This research did not receive any specific grant from funding agencies in the public, commercial, or notfor-profit sectors. This research was conducted under our key job responsibilities. Spink contributed in part under the funding of the MSU Food Fraud Think Tank.
Conflict of interest statement Nothing declared.
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CFSA, Chinese National Center for Food Safety Risk Assessment: Chicago, Illinois, USA: Strategies for Ensuring Food Safety of Chinese Products – fight against food fraud, Presentation at the Institute for Food Technologists (IFT) Annual Conference 2015, Presented by Dr. Junshi Chen 2015. CODEX, Codex Alimentarius: Invitation to Participate in the CCFICS EWG on Food Integrity and Food Authenticity, Home Page for WG on Food Integrity and Food Authenticity – CCFICS 23, August 7, 2017. . [Accessed 05 January 2019], URL: http://www. fao.org/fileadmin/user_upload/codexalimentarius/invitations/EWG %20Kick%20off%20message%20fraud.pdf2017.
10. ISO, International Standards Organization: ISO 12931 – Performance Criteria for Authentication Solutions for AntiCounterfeiting in the Field Of Material Goods. . [cited 2012] [Accessed 05 January 2019], Available from: http://www.iso.org/ iso/catalogue_detail.htm?csnumber=522102011. 11. SSAFE Organization: Home Page. . [cited 2012] [Accessed 05 January 2019], Available from: http://ssafe-food.org/2012. 12. van Ruth SM, Huisman W, Luning PA: Food fraud vulnerability and its key factors. Trends Food Sci Technol 2017, 67:70-75. 13. NFCU, UK National Food Crime Unit: What is Food Crime and How Does it Differ from Food Fraud? Web-page. . [Accessed 05 January 2019], URL: https://www.food.gov.uk/enforcement/ the-national-food-crime-unit/ what-is-food-crime-and-food-fraud2017. 14. Manning L, Soon JM: Food safety, food fraud, and food defense: a fast evolving literature. J Food Sci 2016, 81:R823R834. 15. CEN, European Commission for Standards: CEN WS/86 – Authenticity in the Feed and Food Chain – General Principles and Basic Requirements, Funded under H2020-SFS-2015-1. . [Accessed 05 January 2019], https://www.cen.eu/work/areas/ food/Pages/WS86.aspx2018. 16. EC, European Commission: On the Food Crisis, Fraud in the Food Chain and the Control Thereof. 2014.
21. Clarke RV: Situational crime prevention, chapter 1. In Introduction, in Situational Crime Prevention. Edited by Clarke RV. Guilderland, NY: Harrow and Heston Publishers; 1997. 22. FDA, US Food and Drug Administration: Federal Food, Drug, and Cosmetic Act (FD&C Act). . Home Page, www.FDA.gov [Accessed 15 October 2016] 2015. 23. FDA, US Food and Drug Administration: Food Safety Modernization Act (FSMA).USA: 111th Congress Public Law 353 2011. 24. WHO, World Health Organization: Food Security. . [cited 2009 January 29] [Accessed 05 January 2019], Available from: In: http://www.who.int/trade/glossary/story028/en/2009. 25. GFSI, Global Food Safety Initiative: GFSI Position on Mitigating the Public Health Risk of Food Fraud. Global Food Safety Initiative, Consumer Goods Forum; 2014. 26. GFSI, Global Food Safety Initiative: Food Fraud Technical Document, Tackling Food Fraud through Food Safety Management Systems. . May 9, 2018 [Accessed 05 January 2019], URL: http://www.mygfsi.com/files/Technical_Documents/ 201805-food-fraud-technical-document-final.pdf 2018. 27. DHS, U.S. Department of Homeland Security: DHS Risk Lexicon, Risk Steering Committee. . September 2008 [Accessed 05 January 2019], URL: In: https://www.dhs.gov/xlibrary/assets/ dhs_risk_lexicon.pdf2008. 28. Spink J et al.: Food fraud prevention shifts food risk focus to vulnerability. Trends Food Sci Technol 2017. 29. COSO, Committee of Sponsoring Organizations of the Treadway Commission: Risk Assessment in Practice – Enterprise Risk Management. 2012. 30. SSAFE Organization: Food Fraud Vulnerability Assessment Tool – FFVAT, (Formerly: Safe Secure and Affordable Food for Everyone organization). . December 16 2015, [Accessed January 5, 2019], URL: In: http://www.ssafe-food.org/2015. 31. Spink J, Moyer DC, Speier-Pero C: Introducing the food fraud initial screening model (FFIS). Food Control 2016, 69:306-314. 32. Spink J et al.: Food fraud prevention: policy, strategy, and decision-making–implementation steps for a government agency or industry. CHIMIA Int J Chem 2016, 70:320-328. 33. Spink J, Moyer DC, Whelan P: The role of the public-private partnership in food fraud prevention—includes implementing the strategy. Curr Opin Food Sci (COFS) 2016, 10:68-75. 34. PWC, PriceWaterhouse Coopers Incorporated: Food Fraud Vulnerability Assessment, Online Tool, Produced with SSAFE Organization. . [Accessed 05 January 2019], In: http://www.pwc. com/gx/en/food-supply-integrity-services/publications/ food-fraud-vulnerability-assessment.pdf2016. 35. Cohen LE, Felson M: Social Change and Crime Rate Trends: A Routine Activity Approach. American Sociological Association; 1979:588-608. 36. Spink John: Food fraud prevention. Food Safety and Microbiology. edn 1. New York: Sprinter-Verlag; 2019. [In press].
17. FDA, US Food and Drug Administration: Economically Motivated Adulteration; Public Meeting; Request for Comment, [Docket No. FDA-2009-N-0166]. Federal Register 2009, vol 7415497.
37. Spink John, Zhang Guangtao, Chen Weina, Speier-Pero Cheri: Introducing the Food Fraud Prevention Cycle (FFPC): A Dynamic Information Management and Strategic Roadmap. . [Update 9/8/ 2018, Submitted March 10, 2019] [In press] 2019.
18. CODEX, Codex Alimentarius: Procedural Manual. edn 22. Geneva/ Rome: World Health Organization/Food and Agriculture Organization of the United Nations; 2014.
38. Spink John, Elliott Christopher T, Dean Moira, Speier-Pero Cheri: Fraud data collection needs survey. NPJ Sci Food J (Nat) 2019. [Accepted 00/00/2018] [In press].
19. FDA, US Food and Drug Administration: Thursday, May 26, 2016, 12:00 to 1pm ET: FSMA Public Call: Final Rule on Mitigation Strategies To Protect Food Against Intentional Adulteration, FDA Food Defense Coordination Staff, Presented by Dr. Steve Ostroff and Dr. Ryan Newkirk 2016 . [Accessed 05 January 2019], URL: http://www.fda.gov/Food/GuidanceRegulation/FSMA/ ucm378628.htm.
39. GFSI, Global Food Safety Initiative: Food Fraud Technical Document, Tackling Food Fraud through Food Safety Management Systems. . May 9, 2018, URL: In: http://www.mygfsi. com/files/Technical_Documents/ 201805-food-fraud-technical-document-final.pdf2018.
20. Clarke RV, Eck JE: Crime Analysis for Problem Solvers in 60 Small Steps. Washington, DC: Center for Problem Oriented Policing; 2005. Current Opinion in Food Science 2019, 24:1–9
40. MSU-FFI, Michigan State University’s Food Fraud Initiative: Applying Enterprise Risk Management to Food Fraud Prevention – Workings of ROI vs. Vulnerability, Risk to Vulnerability, and then a case Study Example of a Complex Food Fraud Management System (ERM2), MSU Food Fraud Initiative Report (FFIR). . Funded www.sciencedirect.com
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by the Kerry Group’s Global Supply Quality team’s program, August 2017, URL: http://foodfraud.msu.edu/wp-content/ uploads/2017/09/BKGFF17-FFI-Backgrounder-ERM-ERM2-v46. pdf, URL Video: In: https://youtu.be/DVl_k-7_NEw2017.
44. EU FIP, European Union Food Integrity Project: Food Integrity Project Home Page. . [Accessed 28 May 2019], URL: In: https:// secure.fera.defra.gov.uk/foodintegrity/index.cfm? sectionid=842019.
41. MSU-FFI, Michigan State University Food Fraud Initiative: The Role of Enterprise Risk Management in Food Fraud Prevention. MSU FFIR; 2017.
45. Spink John, Christopher T, Elliott, Kevin P, Swoffer: Defining food fraud prevention to align food science and technology resources. Food Sci Technol 2013, 27:39-42.
42. COSO, Committee of the Sponsoring Organizations of the Treadway Commission: COSO Enterprise Risk ManagementIntegrated Framework Update. . URL: In: http://www.coso.org/ ermupdate.html2014.
46. Spink John: Food fraud prevention – selecting the right test, method, and sampling plan. In DNA Techniques to Verify Food Authenticity: Applications in Food Fraud, Food Chemistry, Function and Analysis Series. Edited by Burns lom, Foster c, Walker cal. Royal Society of Chemistry; 2019. ISBN 1788011783, 97817880.
43. EU FIP, European Union Food Integrity Project: Food Integrity — Case Studies (English), Food Integrity Project Website. . [Accessed 28 May 2019], URL: In: file:///C:/Users/J/AppData/Local/ Microsoft/Windows/INetCache/IE/J9FN3GD8/ FoodIntegrity-Case_Studies_English.pdf2019.
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47. IUFoST, International Union of Food Science and Technology: November 2016: Food Fraud Prevention, Scientific Information Bulletin (SIB) by John Spink 2016 . URL: In: http://iufost.org/ iufost-scientific-information-bulletins-sib.
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Available online at www.sciencedirect.com
ScienceDirect The current state of food fraud prevention: overview and requirements to address ‘How to Start?’ and ‘How Much is Enough?’ John W Spink Food Fraud – intentional deception for economic gain using food – is one of the most urgent and active food research and regulatory areas. The current state of research has expanded to include criminology, public policy, business enterprise risk management, and implementation of a management system. This range of disciplines has been critical since the hazard analy urgent and active food research and regulatory areas. The current state of research has expanded to include criminology, public policy, business enterprise risk management, and implementation of a management system. This range of disciplines has been critical since the hazard analysis, and prevention strategies are fundamentally different when addressing an intelligent human adversary. The broad range of literature has been adopted or adapted to Food Fraud prevention including the identification of the next set of urgent questions: ‘How much is enough?’ and ‘How to start?’ A summary of the literature was provided with a summary of seven questions, two concepts, seven critical steps, and one decision. The seven questions provide a gap analysis to calibrate how much has been completed and how much is still to be done. The two concepts are policy level framing questions for the next activity. The seven steps are for a Food Fraud Task Force that uses the previous insight to create a Food Fraud Prevention Strategy proposal including resource-allocation and key task identification. Finally, the ‘One Decision’ is an official acceptance of the proposed strategy and the ongoing monitoring of the successful and thorough implementation of the management system. This overall method is referred to as the Food Fraud Implementation Method (FFIM). Address Michigan State University, 1124 Farm Lane Road, East Lansing, MI, 48824, USA Corresponding author: Spink, John W ([email protected])
Current Opinion in Food Science 2018, 24:xx–yy This review comes from a themed issue on Food safety
Introduction Food Fraud is one of the most urgent and active food industry topics. While there is evidence of Food Fraud incidents from ancient times and is mentioned in early Chinese writings [1], only in the last few years has the focus shifted from reaction to prevention. The prevention foundation has expanded to include: root cause analysis based in Behavioral Science and Social Science; focused opportunity-reducing measures in Criminology; decisionmaking methods in Public Policy for governments and Enterprise Risk Management (ERM) for industry; Information Technology and Managerial Accounting for monitoring Supply Chain Management and traceability for the flow of product; and an expanded focus on Food Science regarding authenticity confirmation. During this research expansion, there has been ongoing development or re-application of laws, regulations, standards, certifications, and business practices. The research justification of this paper is to review the current state including a very clear explanation of the requirements and then provide several concepts and steps for an enterprise – whether a company, country, NGO, association, or supplier – to strategically and methodically address the problem.
Background Because of an increased consumer and government awareness of food fraud, there is an increased awareness of the public health vulnerability and more significant economic impact of an incident. The increased focus has led to food fraud-specific compliance requirements beyond governments to private certifications and standards. Since food fraud is a root cause of some food safety incidents, a proactive approach will reduce the overall public health and economic risks. The foundational concepts of the food fraud definition and requirements will be covered in more detail before addressing ‘How to start?’ and ‘How much is enough?’
Edited by Lawrence Goodridge and John O’Brien
Food fraud defined
2214-7993/ã 2019 Elsevier Ltd. All rights reserved. 2214-7993/ã 2019 Elsevier Ltd. All rights reserved.
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Food Fraud is widely and generally regarded as intentional deception for economic gain using food [2–16]. The types of food fraud include: adulterant-substances (dilution, substitution, concealment, and unapproved enhancements), mislabelling, gray market/diversion, smuggling, theft, and intellectual property rights counterfeiting (Table 1) [2]. A term related to Food Fraud is economically motivated
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Table 1 Food fraud types, definitions, and examples (as published by GFSI [26] which references [2,4,25,30,32,34] GFSI (1) type of food fraud
Definition from SSAFE (2)
Examples from GFSI FFTT (3)
General type of food fraud
Dilution
The process of mixing a liquid ingredient with high value with a liquid of lower value.
Adulterantsubstance (adulterant)
Substitution
The process of replacing an ingredient or part of the product of high value with another ingredient or part of the product of lower value. The process of hiding the low quality of a food ingredients or product.
Watered down products using nonpotable/unsafe water Olive oil diluted with potentially toxic tea tree oil Sunflower oil partially substituted with mineral oil Hydrolyzed leather protein in milk Poultry injected with hormones to conceal disease Harmful food colouring applied to fresh fruit to cover defects Melamine added to enhance protein value Use of unauthorized additives (Sudan dyes in spices)
Adulterantsubstance or tampering
Expiry, provenance (unsafe origin) Toxic Japanese star anise labeled as Chinese star anise Mislabeled recycled cooking oil Sale of excess unreported product Product allocated for the US market appearing in another country Copies of popular foods not produced with acceptable safety assurances Counterfeit chocolate bars
Tampering
Concealment
Unapproved enhancements
Mislabelling
The process of adding unknown and undeclared materials to food products in order to enhance their quality attributes. The process of placing false claims on packaging for economic gain.
Grey market production/theft/diversion
Outside scope of SSAFE tool.
Counterfeiting/intellectual property rights
The process of copying the brand name, packaging concept, recipe, processing method, and so on. of food products for economic gain.
Adulterantsubstance or tampering
Adulterantsubstance or tampering
Overrun, theft, or diversion (5) Counterfeiting
Notes: (1) GFSI — Global Food Safety Initiative. (2) SSAFE — Safe Secure and Affordable Food for Everyone. (3) GFSI FFTT — Global Food Safety Initiative: Food Fraud Think Tank. (4): Gray Market — a market employing irregular but not illegal methods; Theft — something stolen. (5): Diversion/ Parallel Trade — the act or an instance of diverting straying from a course, activity, or use. Comment: This table is used as the types of fraud list and definitions in the GFSI Food Fraud Technical Document published in 2018. That report is a reference for GFSI compliance.
adulteration (EMA) where the U.S. Food and Drug Administration’s working definition requires a ‘substance’ that is added or deleted for ‘economic gain’ [17]. This definition of EMA is equivalent to an ‘adulterant-substance’ type of Food Fraud. The types of products include: raw materials, incoming goods, goods in manufacturing, goods in storage, products at retailers, and also through consumption to the destruction of food and food packaging. Also, to address what is the role of industry in food fraud prevention it is important to review the types of industry stakeholders: Industry is defined as: producers, manufacturers, food distributors, retailers, academics/strategy researchers, technology suppliers including authenticity affirmation (e.g. test, transaction analysis, or external component), data management, investigator, auditor, market monitors, and others. Food Fraud is one of the four food risks that include Food Quality, Food Safety, Food Fraud, and Food Defense. From Codex Alimentarius, Food Quality is ‘all the attributes that influence a product’s value to the consumer . . . . and positive attributes such as the origin, colour, flavour, Current Opinion in Food Science 2019, 24:1–9
texture and processing method of the food’ [18]. Generally, this is meeting the specification of the buyer or consumer. Also from Codex Alimentarius, Food Safety is the set of activities that lead to ‘assurance that food will not cause harm to the consumer when prepared and/or eaten according to its intended use’ [18]. Food Defense is defined as programs created to protect against an intentional act with the objective to cause harm such as psychological terror, economic harm, or a public health threat [5,26]. It is important to note that the US Food Safety Modernization Act—Intentional Adulteration Final Rule narrows the focus to ‘wide-scale human health harms’ [19]. To note, a related but different term is Food Security which is defined by the World Health Organization as enough food calories, better food nutrition, and then to increase prosperity for the individuals and the society in general [24]. The Food Risk Matrix presents the relationship between Food Fraud, Food Quality, Food Safety, and Food Defense segmented by the basic action and motivation of the problem (Figure 1) [2]: www.sciencedirect.com
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Figure 1
Food
Motivation
Food
Gain:
Quality Food
Fraud Food
Economic Harm:
Safety
Defense
Unintentional
Intentional
Public Health, Economic, or Terror
Action Current Opinion in Food Science
The food risk matrix [2].
Food fraud prevention: applying criminology to the human adversary
It has been said, ‘if the biological organism in question was a microbe you would apply the discipline of microbiology; for food fraud, the biological organism in question is a human so naturally, you would apply the Social Sciences and Criminology’ [1]. A major shift in addressing Food Fraud was to apply Criminology theory to both understand the root cause and – more importantly – understand how to reduce the factors or vulnerabilities that enable the problem to occur in the first place. When beginning to address an emerging issue such as Food Fraud, Criminology theory refers to a problem which is ‘ . . . the basic unit of police work rather than a crime, a case, calls, or incidents’ [20]. ‘A problem is something that concerns or causes harm to citizens, not just the police. [ . . . ] Addressing problems means more than quick fixes: it means dealing with conditions that create problems’ [20]. Food Fraud fits the Criminology classification of a ‘complex problem’ that is most efficiently addressed by opportunity reducing measures – rather than pursuing and apprehending the perpetrators – that control the space where crime occurs. The criminology focus of Situational Crime Prevention is more on reducing the temptations of the physical space rather than a study of the criminals, themselves. When considering the food fraud ‘problems,’ there is so much variation in the target, criminal, and type of criminal opportunity, it is most efficient to focus on reducing the opportunity. While it is essential to pursue and prosecute food fraudsters who are caught ‘as we will never test our way to food safety, we will not arrest our way to safety.’ The goal is not to catch food fraud but to prevent it from occurring in the first place. Applying Environmental Criminology, and more specifically Situational Crime Prevention, provides resources to www.sciencedirect.com
understand the root cause of the problem, select countermeasures and controls systems, and conduct ongoing monitoring. The Criminology-based SARA Model (Scanning, Analysis, Response, and Assessment) is a continuous improvement cycle akin to quality management ‘plan-do-check-act’ tools and other risk management systems [20]. Situational Crime Prevention theory is defined as ‘opportunity-reducing measures that are directed at highly specific forms of crime, involve management, design, or manipulation of the immediate environment in as a systematic and permanent way as possible, and make crime more difficult or risky, or less rewarding and excusable as judged by a wide range of offenders’ [21]. This is founded on several other Criminology theories including Rational Choice Theory and Routine Activities Theory. The Rational Choice Theory considers that criminals believe they can successfully and profitably complete the criminal act therefore they choose to commit a crime. The Routine Activities Theory suggests that criminals often find opportunities for committing crimes during their regular daily activities. These theories are combined in another Criminology analytical tool—the Crime Triangle. Here a victim, a fraudster, and a guardian or hurdle gap are the three required components to enable a ‘motivated offender’ and dimension the fraud opportunity (Figure 2) [20].
Enterprise risk management/COSO The Sarbanes-Oxley Act of 2002 (SOX or Sarbox) is a requirement for all public companies that operate in the U.S. that include companies listed on the New York Stock Exchange [29]. To meet this U.S. regulatory requirement, five of the leading financial and managerial accounting associations built upon previous work by the Committee of the Sponsoring Organizations of the Treadway Commission (COSO). The Treadway Commission, itself, was previously created in 1985 by the National Commission on Fraudulent Financial Reporting which is referred to as The Treadway Commission after the first Chairman, James C. Treadway. The activity expanded in 2004 when the Enterprise Risk Management frame was created and Figure 2
Guardian & Hurdle Gaps
VicƟm Fraud Opportunity Fraudster Current Opinion in Food Science
The crime triangle including victim, fraudster, and guardian and hurdle gaps [35]. Current Opinion in Food Science 2019, 24:1–9
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then expanded in 2017 with the publication of ‘Enterprise Risk Management—Integrating with Strategy and Performance,’ which highlights the importance of considering risk in both the strategy-setting process and in driving performance’ [29]. The motivation for creating COSO, and expanding the ERM concept in 2009 and 2017, was ‘in response to senior executives’ need for effective ways to better control their enterprises and to help ensure that organizational objectives related to operations, reporting, and compliance are achieved’ [29]. Enterprise Risk Management (ERM) is a structured approach to managing risk across an organization that could be a company, government, or any entity. The key concepts are that all risks across an enterprise should be calibrated and coordinated with all other risks. There is a common ‘risk threshold’ that should be managed through Internal Controls (a common set of practices and procedures) and an Integrated Framework (a way to calibrate and coordinate interdisciplinary activities). From COSO/ERM: ‘Internal controls: A process, effected by an entity’s board of directors, management and other personnel, designed to provide reasonable assurance regarding the achievement of objectives in the following categories: effective and efficiency of operations, reliability in financial reporting, and compliance with applicable laws and regulations. An internal control system is a synonym for internal controls applied in an entity’ [42]. ‘Integrated frameworks: Are defined as interconnectivity of internal controls to coordinate operations as well as provide an overall monitoring and calibrating system’ [42].
Sarbanes–Oxley requires the Board of Directors – including the CEO/CFO and the corporate auditor – to sign a legal regulatory document confirming that the Corporate Annual Report confirms all risk is within the threshold or disclosed (see publicly disclosed 10-Q and 10-K reports). While this is a U.S. requirement, often there are similar requirements found in other countries [29]. Non-U.S. and private companies who are not subject to these SOX laws commonly require a similar – if not identical – Internal Control and Integrated Framework. COSO noted that ‘This framework has become the most widely used internal control framework in the U.S. and has been adapted or adopted by numerous countries and businesses around the world’ [29]. It is important to note that food safety and operational employees of food companies are often not aware that their quality control activities support these corporate-level regulatory requirements. Such requirements are commonly supported and documented through COSO/ERM methods and tools. Current Opinion in Food Science 2019, 24:1–9
Since COSO/ERM is a widely adopted system, there is extensive education, training, certification, and auditing. One Food Fraud related COSO/ERM focus is in the process step of Risk Assessment. Within risk assessment, there is a discipline to identify new or emerging problems. COSO prescribes a method for assessments [29]: ‘Assessing risks consists of assigning values to each risk and opportunity using the defined criteria. This may be accomplished in two stages where an initial screening of the risks is performed using qualitative techniques followed by a more quantitative analysis [detailed assessment] of the most important risks’ [29].
Compliance requirements
Food Fraud is usually already illegal under one law or another—whether food safety, misbranding, mislabeling, consumer fraud, smuggling, intellectual property rights, or related criminal acts such as theft. That said, Food Fraud is usually not holistically addressed by a single law or even a single agency [36]. This was concluded in the U.S. Congressional Research Service’s report on ‘Food Fraud and Economically Motivated Adulteration.’ It notes, ‘ . . . that Congress has not addressed food fraud in a comprehensive manner’ [6]. Specifically, ‘no single federal agency or US law directly addresses Food Fraud.’ In the U.S. the primary food-related public health agency is the U.S. Food and Drug Administration. It prioritizes health hazards while emphasizing all types of Food Fraud has been illegal since at least 1938 when the Food, Drug and Cosmetics Act (FDCA) was published. This act includes sections on ‘Adulterated Foods’ and also a separate section on ‘Misbranded Foods’ [22]. Building upon the FDCA, a major update of US Food Laws occurred within the implementation of the Food Safety Modernization Act of 2011 (FSMA). Further, while not specifically mentioned by name, conducting a Food Fraud Vulnerability Assessment for all types of fraud and for all products is explicitly a requirement of the Food Safety Modernization Act [22,23]: 21 CFR 117.130 and 507.33 Hazard Analysis [22]: “(a) (1) you must conduct a hazard analysis to identify and evaluate . . . known or reasonably foreseeable hazards . . . ” “(2) The hazard analysis must be written regardless of its outcome.” “(iii) The hazard may be intentionally introduced for purposes of economic gain.” Another important consideration is the industry standards that are often a requirement for conducting business. One of the most widely adopted private standards is based on the Global Food Safety Initiative (GFSI) Benchmarking Document [5]. GFSI was created by the 300+ global www.sciencedirect.com
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Food fraud overview FFIM Spink 5
corporate members of the Consumer Goods Forum (CGF) to harmonize and standardize the industry practices. GFSI is led by some of the world’s largest food manufacturers and retailers who have continued efforts to engage medium, small, and micro-sized companies. The Food Safety standards are created and managed by quality program owners such as BRC, FSSC 22000, IFS, SQF, and others. A food producer, manufacturer, or brand owner company would seek compliance with those food safety standards which, in turn, would seek GFSI endorsement—thus, the reference to a ‘GFSI compliance standard.’ Reportedly over 65% of the world food trade is conducted by members of GFSI and compliance is critical for companies to be able to conduct commerce. Many of those members are at the end of the supply chain – such as retailers and manufacturers – so their influence is very broad. Many companies have stated there are two paths to becoming a new supplier for them regarding a Food Safety Management System: (1) currently GFSI compliant and (2) soon to be GFSI compliant. As of January 2018, the GSFI Food Safety Management System is required – it is NOT optional – to include: (1) a Food Fraud Vulnerability Assessment that is updated and (2) a Food Fraud Prevention Strategy/Mitigation Plan that is implemented [4]. GFSI requires separate assessments for Food Safety (HACCP), Food Fraud (VACCP) and for Food Defense (TACCP) [25,26]. The three separate assessments must be correlated under the overall Food Safety Management System.
step is framing the question or defining the goal, scope, and objective of the activity.
Framing the question Addressing Food Fraud has broadened the scope of traditional food safety incidents to address all related root causes, the risk assessment for an entire company broadened from known, high-frequency incidents to all related vulnerabilities [38,39]. The focus has been on a proactive vulnerability reduction or elimination of the root causes of problems of the problems. A vulnerability is different from a risk or hazard as mitigation and prevention are unique activities. ‘The US Department of Homeland Security describes vulnerability and risk as follows [27]: Vulnerability. A physical feature or operational attribute that renders an entity open to exploitation or susceptible to a given hazard.’ Risk. The potential for an unwanted outcome resulting from an incident, event, or occurrence, as determined by its likelihood and the associated consequences’ [27]. The management focus is on prevention rather than mitigation [28]: ‘Mitigation: is intended to reduce the consequence of the event.’ ‘Prevention: is intended to reduce or eliminate the likelihood of the event occurring.’
Once the Food Fraud Vulnerability Assessment has been conducted and the Food Fraud Prevention Strategy is created and implemented, there can be an identification of the food fraud vulnerabilities that are above the risk tolerance. Once those specific problems are identified, a Situational Crime Prevention analysis can be conducted to identify where/when/how/why a system weakness has been exploited. Once that ‘hot product’ and ‘hot spot’ [21,22] have been identified, there can be an assessment of the most efficient and effective countermeasures and control systems that will reduce the fraud opportunity. For example, the European Union funded Food Integrity Project (EU FIP) developed a wide range of food authenticity research projects [43,44]. Once the Food Fraud Prevention Strategy is implemented, there can be an evaluation of the efficiency and effectiveness of food authenticity tests [45,46,47].
To clarify, prevention assumes that the root cause of the event could be eliminated or at least greatly reduced in terms of likelihood of occurrence. Also, mitigation assumes the event will frequently occur, so there is a goal to mitigate or reduce the negative consequence.
For a more thorough explanation of a method to manage information and work activities see the research on the Food Fraud Prevention Cycle (FFPC) [37]. To address ‘How much is enough?’ there is a Food Fraud Implementation Method (FFIM) to assess the problem and create an efficient and effective management system. The first
For framing the question of the project scope, for Food Fraud prevention, the concept of an initial screen or prefilter is consistent with concepts such as ISO 31000 Risk Management and has been noted in reports such as by the U.S. Pharmacopeia, SSAFE Organization, PWC/ SSAFE, WUR/ SSAFE, and GFSI [26,30]. One specific
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The Food Fraud regulatory or standards requirements are not very detailed with respect to actual tools or techniques. Conversely for Food Safety and Food Defense, there are quite a bit of detailed and prescriptive assessment approaches such as in the U.S. Food Safety Modernization Act Final Rules for Preventive Controls (Food Safety) and Intentional Adulteration (Food Defense). The financial regulatory and standards requirements provide more details such in the U.S. Sarbanes-Oxley Act of 2002 and the subsequent COSO/Enterprise Risk Management system (COSO/ERM).
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application is ‘Introducing the Food Fraud Initial Screening Tool (FFIS)’ [31]. The best practice for food fraud risk assessment is to first conduct a quick pre-filter or initial screen but to make sure it covers ALL types of fraud and ALL products. Once this first assessment (the initial screen, FFIS) is completed there can be an identification of where more information is needed or where a more detailed assessment is warranted (the detailed vulnerability assessment, FFVA). Subsequent periodic assessments should then explore vulnerabilities in more detail.
How to start? Address seven questions, two concepts and seven steps
Once the basic concepts are understood, the impost important and often most challenging next step for creating a Food Fraud Prevention Strategy is ‘How to start?’ by following the Food Fraud Implementation Method (FFIM) through ‘7 questions, 2 Concepts and 7 Steps’ [32,33]. The first activity is to conduct a gap analysis to understand how much has been accomplished and how much still needs to be done. The seven questions provide a gap analysis to calibrate how much has been completed and how much is still to be done’ [32,33]. Seven questions Conduct a Food Fraud Vulnerability Assessment (Y/N) Written (Y/N) Implement a Food Fraud Prevention Strategy (Y/N) Written (Y/N) Minimally conduct an annual Food Fraud Incident Review (Y/N) 6 Note: Address all types of Food Fraud (Y/N) 7 Note: Address all products from both incoming goods (e.g. ingredients) and outgoing goods (e.g. finished goods) through to the consumer.’
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The second activity is to establish two basic concepts that set the foundation for future activities. These provide a policy-level framing or foundational starting point for the next, third step. This step helps to evaluate how an organization should specialize in specific food fraud prevention responsibilities and other fraud prevention countermeasures or control systems. This will identify the touch-points between departments and also where there is duplicity such as between corporate security, food safety, and supply chain management. By clearly defining the scope and policy authority there can be guidance on the project management and final implementation. If a clear corporate policy directive is identified and agreed, then a situation is created where a department would violate a corporate policy if they decided to ‘opt-out’ of the activity. Current Opinion in Food Science 2019, 24:1–9
Two basic concepts 1 Concept One—Formally, and specifically, mention food fraud as a ‘food’ issue While this seems simple, there is often confusion as to whether fraud is to be managed by Corporate Security, Supply Chain Management, Purchasing, or corporate functions. By declaring these frauds to be exclusively related to ‘food’, it clearly becomes the domain of food safety and food quality assurance functions. It should be expected that these traditional food safety resources will require corporate assistance from non-traditional resources such as brand protection activities. ‘An example of an agency or company policy statement created is: ‘This statement confirms that AGENCY/ COMPANY expects the food industry to conduct risk or vulnerability assessments, including mitigation or prevention plans where warranted, on all incidents that could lead to a health hazard or the violation of a food law such as the FSMA or the FD&C. This includes all Food Fraud such as adulterant-substances, tampering, theft, illegal diversion or gray markets, illegal mislabeling, and intellectual property rights or product counterfeiting, and others. Consistent with existing Federal and State laws and regulations, third-party certifications play an important role in supporting this type of food supply chain protection’ [33]. 2 Concept Two—Create an enterprise-wide Food Fraud prevention plan After these two concepts are established the third activity is to initiate a project – or referred to here as a task force – that will propose the optimal Food Fraud Prevention Strategy. The seven steps are for a Food Fraud Task Force that uses the previous insight to create a Food Fraud Prevention Strategy proposal including resource-allocation and key task identification. Food fraud task force steps (7 steps) From a business management standpoint, it is most efficient for an executive sponsor to assign this responsibility to a ‘Food Fraud Task Force,’ clearly require addressing these issues below, and then set a due date. The task force is important since a scope that covers all types of fraud and for all products usually is interdisciplinary and involved responsibilities that are distributed across many departments. Once a thorough, holistic, final report is submitted to the executive sponsor, there can be a direct and thorough review of the proposal, identify questions, recommend adjustments, or seek answers to specific questions. This final report can be shared within the enterprise for consideration of compliance, general liability or adjusted human resource needs. The general steps for implementing and managing Food Fraud Prevention include: www.sciencedirect.com
Please cite this article in press as: Spink JW: The current state of food fraud prevention: overview and requirements to address ‘How to Start?’ and ‘How Much is Enough?’, Curr Opin Food Sci (2019), https://doi.org/10.1016/j.cofs.2019.06.001
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1 Convene a Food Fraud Task Force 2 Create an Enterprise-wide Food Fraud Policy/Mission Statement and begin drafting a Food Fraud Prevention Strategy/Plan 3 Conduct the pre-filter Food Fraud Initial Screening (FFIS) 4 Review additional needs including additional information or a more detailed Food Fraud Vulnerability Assessment (FFVA) 5 Review-specific Food Fraud vulnerabilities in an enterprise risk map (Enterprise Risk Management) 6 Consider countermeasures and control systems to address the ‘very high’ and ‘high’ vulnerabilities 7 Propose a Food Fraud Prevention Strategy including the calibration of the Food Fraud risks on the enterprise risk map A formal report should document all actions and findings for managerial review and oversite. The receipt of the complete and direct task force proposal can lead to requests for specific additional information and informed resource allocation. Of note, a decision to not implement recommendations or implement changes is a decision to accept the status quo. Finally, the fourth activity is the ‘One Decision’ which is an official acceptance of the proposed strategy and the ongoing monitoring of the successful and thorough implementation of the management system. In some situations, ‘no decision’ – no formal acceptance or rejection of the Food Fraud Task Force proposal – is a de facto acceptance of the current state as acceptable. A non-decision by the executive sponsor regarding the proposal could be found in a future audit.
How much is enough? The Food Fraud Implementation Method (FFIM) – including the seven questions, two concepts, seven steps, and one decision – creates an overall management system including the enterprise risk management assessment of the vulnerabilities (for more see Refs. [40,41]). When the results are plotted on a corporate risk map then there is a calibration of the food fraud vulnerabilities in relation to all other enterprise-wide risks. The process creates a clear identification of the vulnerabilities that are above the risk tolerance and then the extent of the countermeasures or control systems that eventually identify ‘How much is enough?’ Identify the vulnerabilities Assess the vulnerabilities using an enterprise-wide scale for likelihood and consequence Rank the vulnerabilities on a risk map in relation to all enterprise-wide risks Identify which vulnerabilities are above the enterprise determined risk tolerance Propose projects that will reduce the vulnerability of the specific problems to within the risk tolerance www.sciencedirect.com
Report that the vulnerabilities are all within the risk tolerance or disclose the non-conformities The implementation of the FFIM – including the activities presented in the FFIS and FFPC – provide a management system to conduct a risk assessment and determine the appropriate risk treatment or the ‘How much is enough?’ question.
Conclusion The Food Fraud research scope has been expanding to include management systems and methods that address implementation. The expansion from ‘what’ is food fraud and ‘severity’ to the practical implementation problem brings up new questions of ‘How to start?’ and ‘How much is enough?’ These new questions require utilizing different disciplines such as criminology, public policy, business enterprise risk management, and then management of the activities. The broadening scope from ‘How to detect fraud?’ to a management system implementation scope creates a shift in focus from the detection of the immediate public health harms to the reducing the overall vulnerability for entire companies or countries. While the disciplines such as criminology and managerial accounting may not be familiar to food scientists yet, they are familiar across a company or country. These disciplines have long-established research and support including training, education, and certification. For those who are new to addressing Food Fraud prevention, there is a thorough and competent body of literature to address ‘how to start?’ and ‘how much is enough?’ The first step is to be confident in taking a holistic and all-encompassing scope with a very light first initial screening. By breaking the complex problem into simple steps, the first steps are logical.
Funding sources This research did not receive any specific grant from funding agencies in the public, commercial, or notfor-profit sectors. This research was conducted under our key job responsibilities. Spink contributed in part under the funding of the MSU Food Fraud Think Tank.
Conflict of interest statement Nothing declared.
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