food fraud food safety summit 2014 - thermo …...• defined the focus as “food fraud and...

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Food Fraud: Overview & Update

Doug Moyer, PhD, CPP

Food Fraud Initiative Michigan State University

Food Safety Summit Baltimore April 9, 2014

*

Food Fraud Doug Moyer, PhD, CPP Michigan State University

• Researcher, Food Fraud Initiative, College of Veterinary Medicine

• Lead Instructor, Program in Public Health, College of Human Medicine

• Researcher, Center for Anti-Counterfeiting and Product Protection (A-CAPP),

School of Criminal Justice © 2014 Michigan State University

•  Food Fraud Overview 1.  DefiniBon of Food Fraud 2.  Food Risk Matrix 3.  Types of Food Fraud, Fraudsters, and Public

Health Risks 4.  Strategies

Food Fraud PresentaBon Agenda

© 2014 Michigan State University

•  Food Fraud Update •  Next Speaker •  Discussion

Food Fraud PresentaBon Agenda, cont.


Acknowledgement

John Spink, PhD Director, Food Fraud Initiative

[email protected]

FoodFraud.msu.edu

Twitter @FoodFraud and #FoodFraud

1. Definition of Food Fraud

FoodFraud.msu.edu © 2014 Michigan State University

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© 2014 Michigan State University 7 © 2013 John Spink 7

•  Define the foundation, terminology, and prevention.

FoodFraud.msu.edu

What is Food Fraud? Food fraud is a collecBve term used to encompass… •  the deliberate and intenBonal… •  subsBtuBon, addiBon, tampering, or misrepresentaBon of…

•  food, food ingredients, or food packaging; •  or false or misleading statements made about a product,

•  for economic gain.


Spink, John, & Moyer, Douglas C. (2011). Defining the Public Health Threat of Food Fraud. Journal of Food Science, 76(9), R157-162.

How is Food Fraud Unique?

•  Deliberate and intenBonal (acBon) •  For economic gain (moBvaBon) •  Food Fraud differs from:

– Food Safety – Food Quality – Food Defense


2. Food Risk Matrix



2. The Food Risk Matrix

Ac#on IntenBonal UnintenBonal

Harm:

Public Health, Economic, or

Terror

Food Defense

Food Safety

Mo#va#on

Gain: Economic

Food Fraud

Food Quality

Dis#nc#ve Causes have different Effects Understanding Mo#va#ons is the Key to Preven#on

Source: Adapted from: Spink (2006), The Counterfeit Food and Beverage Threat, AssociaBon of Food and Drug Officials (AFDO), Annual MeeBng 2006; Spink, J. & Moyer, DC (2011) Defining the Public Health Threat of Food Fraud, Journal of Food Science, November 2011

Food

Sec

urity

How is Food Fraud Unique? (conBnued)

•  Food Fraud is an economically moBvated act that can easily have public health risks… – because fraudsters aren’t moBvated by good manufacturing pracBces or regulaBons.

•  The public health risks are potenBally more risky than the tradiBonal food safety threats… – because adulterants are unconvenBonal… – and these contaminants are not specifically being looking for.


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3. Types of Food Fraud, Fraudsters, and Public Health Risks


What are the Different Types of Food Fraud?

•  AdulteraBon •  Tampering •  Over-‐run •  Thed


Spink, John, & Moyer, Douglas C. (2011). Defining the Public Health Threat of Food Fraud. Journal of Food Science, 76(9), R157-162.

•  Diversion •  SimulaBon •  CounterfeiBng

Types of Food Fraud Term Defini#on Example

AdulteraBon A component of the finished product is fraudulent Melamine added to milk

Tampering LegiBmate product and packaging are used in a fraudulent way

Changed expiry informaBon, product up-‐labeling, etc.

Over-‐run LegiBmate product is made in excess of producBon agreements

Under-‐reporBng of producBon

Thed LegiBmate product is stolen and passed off as legiBmately procured

Stolen products are co-‐mingled with legiBmate products.

Diversion The sale or distribuBon of legiBmate products outside of intended markets

Relief food redirected to markets where aid is not required

SimulaBon IllegiBmate product is designed to look like but not exactly copy the legiBmate product

“Knock-‐offs” of popular foods not produced with same food safety assurances

CounterfeiBng Intellectual Property Rights infringement, which could include all aspects of the fraudulent product and packaging being fully replicated

Copies of popular foods not produced with same food safety assurances


GAO Seafood Fraud Report: Types of Food Fraud and Poten#al Public Health Risk


Source: Food Fraud Think Tank Presentation, GFSI, 10/2012

Tampering Over-Runs

What is Food Fraud?

Food Fraud

Dilution Contaminant

Grey Market/ Theft/ Diversion Counterfeiting

Unapproved Enhancements

Mislabeling

Substitution

FD&C Act Adulteration


Types of Counterfeiter Criminals

•  RecreaBonal •  Occasional •  OccupaBonal (Employee) •  Professional •  Ideological (Spink, Moyer, Park & Heinonen, 2013; 2014)


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What are the Public Health Risks? •  Direct food fraud risk: immediate or imminent risk to the

consumer, such as the inclusion of an acutely toxic or lethal contaminant.

•  Indirect food fraud risk: consumer is at risk through long-‐term exposure, such as the build up in the body of a chronically toxic contaminant through the ingesBon of low doses. Indirect risk also includes the omission of beneficial ingredients, such as preservaBves or vitamins.

•  Technical food fraud risk: non-‐material in nature. For example, food documentaBon fraud occurs when product content or country-‐of-‐origin informaBon is deliberately misrepresented.


4. Strategies


What is a MulBdisciplinary Approach to Food Fraud?

•  Food Science •  Packaging Science •  Supply Chain Management (LogisBcs) •  Crime Science (Criminology)


Why Is Packaging Important To Food Fraud? •  Packaging protects food, conveys product informaBon, and adds funcBonality for consumers

•  Packaging balances the needs of manufacturers, transporters, and consumers

•  Packaging can also: – provide anB-‐counterfeiBng security features – enable product track-‐and-‐trace and pedigrees –  facilitate product authenBcaBon by consumers and law enforcement officials


Why is Supply Chain Management Important to Food Fraud?

•  Knowing the source and history of foods is important •  Fraudsters perpetuate their crimes through vulnerabiliBes in

food supply chains •  End-‐to-‐end visibility and supply chain transparency are criBcal

management tools for brand owners •  Supply chain management can also enable:

–  tracking and tracing that creates product pedigrees –  market monitoring –  product tesBng –  effecBve and efficient product recalls and quaranBne acBons


Why Is Criminology Important To Food Fraud?

•  Food fraud is an illicit acBvity that human actors perpetrate for economic gain

•  Crime science studies crime events and criminals

•  A useful plaiorm for examining food fraud events and food fraudsters


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Chemistry of the Crime (AKA SituaBonal Crime prevenBon) The Crime Triangle (Opportunity) •  Detect •  Deter •  Prevent

Are we disrupting the chemistry of the crime?

The Opportunity

Guardian/ Hurdles Gaps Victim

Fraudster


(Source: Adapted from Felson, 1998)

What are the Strategies for Food Fraud? FDA Food ProtecBon Plan

•  PrevenBon –  increasing corporate responsibility to prevent food-‐borne

illnesses –  idenBfying food vulnerabiliBes and assess risks –  expanding the understanding and use of effecBve miBgaBon

measures

•  IntervenBon –  focus inspecBons and sampling based on risk –  enhance risk-‐based surveillance –  improve the detecBon of food system “signals” that indicate

contaminaBon

•  Response –  improve immediate response –  improve risk communicaBons to the public, industry and other

stakeholders (FDA Food ProtecBon Plan, Fact Sheet, 2008)

Adulteration

Food Protection

REMOVE

FS FD

Prevent

FF


A Strategic Solution to Food Fraud •  Monitoring all imported product is not

practical. •  Monitoring all international food

manufacturing is not practical. •  Agencies are implementing, not making,

laws: Participate in rulemaking •  Focus on the root of the risk and actions…

–  The chemistry of the crime: Criminal, Victim, and Opportunity

•  Food Fraud IS our responsibility •  The Strategy

–  Intelligence Gathering –  Create a Public Forum –  Create Awareness & Harmonization (Source: Spink, 2009, AAAS Conference)


Food Fraud Update


Food Fraud Update: US •  General government shid from reacBon to

preven&on –  Demonstrated in the 2011 Food Safety ModernizaBon Act (FSMA) that specifically menBons preven&on 70 Bmes.

–  FSMA SecBon 106 – Focused MiBgaBon Strategies to Protect Food Against Inten&onal Adultera&on

•  Congressional Research Service (CRS) report on Food Fraud and Economically MoBvated AdulteraBon of Food


Food Safety Modernization Act •  11 Mentions of “Intentional Adulteration” •  Section 106. Protection against intentional adulteration

–  “103 (1) identify and evaluate known or reasonably foreseeable hazards that may be associated with the facility… (2) identify and evaluate hazards that may be intentionally introduced, including by acts of terrorism… (3) develop a written analysis of the hazards.”

–  “106 (b)(1) [HHS w/ DHS & USDA]… shall issue guidance documents related to protection against the intentional adulteration of food, including mitigation strategies or measures to guard against such adulteration as required under section 402 of the FD&C…”

–  “106(a)(1)(C) determine the types of science-based mitigation strategies or measures that are necessary to protect against the intentional adulteration of food.”


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SEC. 106. PROTECTION AGAINST INTENTIONAL ADULTERATION

•  (a) In General- Chapter IV (21 U.S.C. 341 et seq.), as amended by section 105, is amended by adding at the end the following:

•  `SEC. 420. PROTECTION AGAINST INTENTIONAL ADULTERATION. •  `(a) Determinations- •  `(1) IN GENERAL- The Secretary shall-- •  `(A) conduct a vulnerability assessment of the food system,

including by consideration of the Department of Homeland Security biological, chemical, radiological, or other terrorism risk assessments;

•  `(B) consider the best available understanding of uncertainties, risks, costs, and benefits associated with guarding against intentional adulteration of food at vulnerable points; and

•  106(a)(1)(C) determine the types of science-based mitigation strategies or measures that are necessary to protect against the intentional adulteration of food.


`SEC. 418. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS

•  `(a) In General- The owner, operator, or agent in charge of a facility shall, in accordance with this section, evaluate the hazards that could affect food manufactured, processed, packed, or held by such facility, identify and implement preventive controls to significantly minimize or prevent the occurrence of such hazards and provide assurances that such food is not adulterated under section 402 or misbranded under section 403(w), monitor the performance of those controls, and maintain records of this monitoring as a matter of routine practice.

•  `(b) Hazard Analysis- The owner, operator, or agent in charge of a facility shall-- •  `(1) identify and evaluate known or reasonably foreseeable hazards that may

be associated with the facility, including-- •  `(A) biological, chemical, physical, and radiological hazards, natural toxins,

pesticides, drug residues, decomposition, parasites, allergens, and unapproved food and color additives; and

•  `(B) hazards that occur naturally, or may be unintentionally introduced; and •  `(2) identify and evaluate hazards that may be intentionally introduced,

including by acts of terrorism; and •  `(3) develop a written analysis of the hazards.


FSMA IA Update •  Public Meetings to 3/13 •  IA includes “catastrophic

event” (traditional Food Defense) •  Disgruntled employees and EMA

moved to Preventative Controls •  FDA is seeking comments on

where and how EMA (including Food Fraud) should be addressed

© 2014 Michigan State University FoodFraud.msu.edu

CRS Report on Food Fraud

•  Defined the focus as “food fraud and ‘economically motivated adulteration’ or EMA, a category within food fraud.”

•  Reinforced that there is no US statutory definition of FF and EMA. Also, that Congress has “not addressed food fraud in a comprehensive manner.” In addition, that “no single federal agency or U.S. law directly addresses food fraud [or EMA].”

•  ”FSMA also recognizes ‘third party’ audits or certifications, and several such entities have already started to address food fraud both in terms of identifying terms or assessing implementation actions such as vulnerability assessments [104]”


Food Fraud Update: InternaBonal •  UK’s Elliot Report •  European Parliament •  GFSI (Global Food Safety IniBaBve) •  Other


UK Elliott Independent Review of Food Fraud •  The importance of a systems approach and preventative

measures – which is consistent with the EU draft resolution on Food Fraud, the USA FDA and the USA Congressional Research Service report.

•  Expanding the research focus from detection to collaborative prevention.

•  As is consistent with many reports from around the world and from research, the report reiterates that Food Fraud is a unique threat that requires specific attention, and although distinctly different, the countermeasures should be integrated with Food Safety, Food Defense, and large scale organized crimes.


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European Parliament Draft Resolution

“Notes that EU law does not currently provide a definition of food fraud and that Member States adopt different approaches; considers a uniform definition to be essential for developing a European approach to combating food fraud; stresses the need rapidly to adopt a harmonized definition at EU level, including elements such as 1) non-compliance with food law and/or misleading the consumer, 2) intent and 3) financial gain;”

“According to Spink and Moyer, ‘Food fraud is a collective term used to encompass the deliberate and intentional substitution, addition, tampering, or misrepresentation of food, food ingredients, or food packaging; or false or misleading statements made about a product for economic gain.”



Global Outreach


!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

Food Safety Modernization Act Section 305

!!!!U.S. Department of Health and Human Services !!!!U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition

February 2013

FDA’s InternaBonal Food Safety Capacity-‐Building Plan


•  Goal 4: Enhance technical assistance and capacity building in food safety –  Objec#ve 4.2 Train foreign governments and

food producers on U.S. requirements for safe food •  4.2.3 PrioriBze training and capacity-‐building acBviBes

according to risk assessments and needs assessments of idenBfied countries, as appropriate.

Global Curriculum Project


•  FDA Office of InternaBonal Programs •  InternaBonal Food ProtecBon Training InsBtute (IFPTI) and the Regulatory Affairs Professionals Society (RAPS)

•  Phase I Outcomes (October 2014) include defining a competency-‐based curriculum for educaBng and training regulatory workforces

Global Outreach: MOOC TranslaBon


http://foodfraud.msu.edu/mooc/

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Call to Action… Application to Food •  US Congressional Research Service Report on Food Fraud •  GMA Brand Protection and Supply Chain Integrity Report •  UK Elliott Independent Review of Food Crimes •  European Parliament Draft Resolution to Define Food Fraud and

focus on Prevention (DG-SANCO) •  Global Food Safety Initiative Including Food Fraud

–  Created a Food Fraud Think Tank •  ISO TC 247 Fraud Countermeasures and Controls •  U.S. Pharmacopeia/ Food Chemicals Codex adulteration working

groups: food ingredients, dietary supplements, medicines •  GAO Report on FDA and EMA •  U.S. FDA Direct Activity

–  US FSMA Draft Rulemaking Asking about EMA –  FDA Working group on “Economically Motivated Adulteration” created

September 2011 – All FDA products –  FDA Food Defense on “Intentional Contamination” – to Preventative Controls

•  Awareness of underlying general business risks… FoodFraud.msu.edu


Discussion


http://foodfraud.msu.edu/mooc/

food fraud food safety summit 2014 - thermo …...• defined the focus as “food fraud and...

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