• If ‘Disgruntled Employee’ Actions Are ‘Economically Motivated’ Is It Food Fraud and Does It Meet the FDA’s Definition of ‘Economically Motivated Adulteration”? No and No.

    by John Spink • August 11, 2014 • Blog • 0 Comments

    emaDoes it matter? Aren’t they all just words? Not if there is a regulatory compliance issue. The US Food Safety Modernization Act (FSMA) is still determining where and how they will address ‘Economically Motivated Adulteration’ (EMA) – and there are questions beyond just the text from the Federal Register or from FSMA (see previous blog post here ). This is a specific type of act, and categorizing the ‘disgruntled employee’ vulnerability is critical when considering prevention countermeasures.

    I had a conversation last week with a multi-national corporation manager who is responsible for food protection. They’re incorporating Food Fraud prevention into their overall quality assurance system. He/she asked “Since the disgruntled employee is trying to economically harm their employer, isn’t this a Food Fraud act since the motivation is ‘economically motivated’ and thus ‘economically motivated adulteration’?” No.

    Food Fraud

    To start from the beginning, the motivation for a Food Fraud act is economic gain for the actor. The motivation for a Food Defense act is most likely to inflict economic, public health, or terror harm to someone else. These are important points when considering how to deter the bad guy – in this case a disgruntled employee – from acting.

    The short definition of Food Fraud from our 2011 Journal of Food Science article is:

    “Any fraud conducted for economic gain using food… including adulteration, theft, tampering, over-runs, diversion (smuggling), simulation (illegal knock-offs), and intellectual property rights infringement counterfeiting.”

    This broad scope Food Fraud definition is used by others including the European Union, the UK Elliott Review (referring to it more as ‘Food Crime’), and the US Congressional Research Service. This definition is also the base for the Global Food Safety Initiative work, the International Standards Organization Technical Committee 247 on Fraud Countermeasures and Controls, and it is also starting to be used by other standards or certification bodies. The definition is also aligned with the UK Food Standards Agency:

    “Food fraud is committed when food is deliberately placed on the market, for financial gain, with the intention of deceiving the consumer.”

    They go on to state, “Although there are many kinds of food fraud the two main types are: the sale of food which is unfit and potentially harmful, and the deliberate misdescription of food.” As with GFSI and others, they specifically address stolen genuine goods when they note “Food Fraud may also involve the sale of meat from animals that have been stolen and/or illegally slaughtered, as well as wild game animals like deer that may have been poached.”

    FDA’s Definition of EMA

    To go back to our Disgruntled Employee question, it must be clearly stated that the FDA formally defined “Economically Motivated Adulteration”. Although it is not defined in a regulation or in the Food Safety Modernization Act (actually, EMA isn’t mentioned in FSMA or the Food, Drug & Cosmetics Act), EMA is a specific and defined concept and not just a common and informal phrase. The Federal Register entry was a notice for the FDA public meeting on EMA. (We were invited by FDA and presented “Defining Food Fraud & the Chemistry of the Crime” at the May 2009 FDA Public Meeting on EMA .)

    From the Federal Register  [my emphasis added]:

    “For purposes of this public meeting, FDA proposes a working definition of EMA as the fraudulent, intentional substitution or addition of a substance in a product for the purpose of increasing the apparent value of the product or reducing the cost of its production, i.e., for economic gain. EMA includes dilution of products with increased quantities of an already-present substance (e.g., increasing inactive ingredients of a drug with a resulting reduction in strength of the finished product, or watering down of juice) to the extent that such dilution poses a known or possible health risk to consumers, as well as the addition or substitution of substances in order to mask dilution.”

    The FDA working definition of EMA only includes “adulteration” – adding a new substance that isn’t supposed to be in the product or reducing the amount of something for economic gain. The Federal Register notice did not mention broader product fraud concepts such as counterfeiting, stolen goods, diversion, or tampering. The four examples in the Federal Register were:

    • Melamine in pet food (an animal food)
    • Oversulfated chondroitin sulfate (OSCS) in Heparin (a prescription drug)
    • Melamine in infant formula (infant formula is defined by FDA as a specific type of human food)
    • Diethylene glycol in cough syrup (an over –the-counter drug)

    The FDA EMA scope covers all FDA regulated products although it’s really only been used for human food. There was emphasis throughout the Federal Register notice on public health risks:

    “The purpose of the meeting is to stimulate and focus a discussion about ways in which the food (including dietary supplements and animal food), drug, medical device, and cosmetic industries, regulatory agencies, and other parties can better predict and prevent economically motivated adulteration with a focus on situations that pose the greatest public health risk.”

    Disgruntled Employee

    To return again to our original question, the action of the disgruntled employee – whether using an adulterant or not — is ‘economically motivated’ (to cause economic harm to the employer) but not in the sense of how the FDA Federal Register Notice defined ‘Economically Motivated Adulteration.’ So, no, the disgruntled employee does not fall under the FDA definition of EMA — it also does not fall under the broader Food Fraud concept.

    Even though the requirements for regulatory compliance are still undefined, there is an immediate value to more clearly defining the act and motivation of the ‘disgruntled employee.’ While food quality, food safety, and food defense countermeasures increase the transparency and security of the supply chain, separately addressing the disgruntled employee threat is important. A focus on Food Fraud prevention countermeasures will only have an indirect impact on preventing the ‘disgruntled employee’ action. JWS.

     

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