• Is EMA a “catastrophic event”? A Review of the Food Fraud Aspects of the FDA Public Meeting on FSMA Intentional Adulteration

    by John Spink • March 6, 2014 • Blog • 0 Comments

    honeyIs an “economically motivated” incident only dangerous “economically”?  This question raises the important point of scope and definition of the “risk” in a “risk based approach.”  From a terrorist attack impact or food safety outbreak perspective an EMA incident almost always has a very low public health impact.  This is an ever-present challenge for Food Fraud strategy-setting.

    This is a review of the Economically Motivated Adulteration (EMA) and Food Fraud aspects of the February 20, 2014 FDA Public Meeting on the Intentional Adulteration section of the Food Safety Modernization Act (FSMA) (http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm377956.htm).  There were no surprises from FDA.  Their comments were consistent with the proposed rule.  FDA confirmed there is no timetable for when – or where — they will address EMA.  As is often the case, the most interesting part of the day was the open question period.

    Formal FDA Presentations

    The title of the Public Meeting was “FSMA Proposed Rule for Focused Mitigation Strategies to Protect Food Against Intentional Adulteration”, and the focus was quickly defined as “…FDA’s proposed rule on food defense.”  The proposed rule states “Acts of intentional adulteration may take several forms, including those where the intention is to cause large-scale public health harm; acts of disgruntled employees, consumers, or competitors; and economically motivated adulteration.”  EMA was defined by FDA as outside the rule since the “The primary purpose of economically motivated adulteration is to obtain economic gain, and not to impact public health, although public health harm may occur.”  As noted in a previous blog post (http://bit.ly/19kjCo7), FDA has defined this rule to include “massive public health harm, including acts of terrorism.” There were also several mentions in the rule and during FDA presentations that the proposed rule is “limited to foods that are at high risk.”

    • Economically Motivated Adulteration (EMA):  FDA stated there is no timetable on when — or where — EMA will be addressed.  They are working out the details of how it will be included in FSMA. The intent is for EMA to be included in the preventative controls sections of FSMA, which were previously addressed.   This timing will allow for new comments that consider recent Food Fraud prevention insights from the European Union referendum on Food Fraud (Jan 10), the US Congressional Research Service report on Food Fraud (Jan 14), the UK PAS 96 TITLE meeting on Food Fraud (Jan 15), the UK Elliott Review of Food Fraud (Dec 18), the UK DEFRA/FSA Food Fraud conference (Feb 27), the UK DEFRA/FERA conference on “Food Fraud – The Analytical Tools” (Feb 27), and the GFSI Food Fraud Think Tank presentation at the GFSI conference (Feb 27).  This is in addition to the older US GAO report, “Better Coordination Could Enhance Efforts to Address Economic Adulteration and Protect the Public Health, Report to Congressional Requesters” (October 2011).
    • Food Defense Impact on Food Protection and Food Fraud:  FDA defined their Intentional Adulteration focus on events “caused by acts of terrorism” that result in “catastrophic events including human illnesses and death.”  Generally, proactive and conscientious companies have already implemented Food Defense plans because it just makes sense.  It’s the rogue or oblivious companies that don’t embrace these plans – these companies create the biggest threat opportunity for the entire food supply chain. FSMA adds teeth to FDA’s bite so there will be more compliance.  The role of any regulation is to at least raise the floor – or minimum requirements – of compliance.  Broader implementation of better Food Defense programs will increase the protection of the entire food supply chain… and will result in a reduction in the fraud opportunity for Food Fraud.  Any new monitoring or control of any supply chain inherently increases transparency.  When we have more vision of the products as they move through the supply chain the fraud opportunity is reduced.
    • Food Defense has Hostile Motives:  There was a continued emphasis by FDA on “a hostile motive… which you cannot study and anticipate in the same way [as food safety].”  The term “hostile” does seem more appropriate for the terrorist attacks and disgruntled employees but it does apply to perpetrators with only intent to economically defraud.  The important point is that FDA continues to note that combating a Food Defense incident is different than combating a Food Safety hazard.
    • Economic Impact:  FDA addressed the issue of how assessing the economic impact of an Intentional Adulteration incident (of any kind) is challenging for events that have very few – if any – occurrences.  FDA stated “since they are low probability events – or events that never happened before – it is very difficult to estimate the impact.” Also, they avoided estimating the cost for a human life (the concepts of QALY-Quality Adjusted Life Years or DALY-Disability Adjusted Life Years).  FDA stated that economists do not put a value on human life and they try to look at consumer prevention actions to find out what value people put on their own lives.  FDA did present economic impacts for Food Defense and we will review those in more detail after the presentation and transcript are released.

    Question and Answer Period

    By necessity, public meetings are usually pretty scripted, especially during an open comment period.  The government agencies are extremely limited in what they can say.  The topics of “EMA” and “Disgruntled Employees” were mentioned by several speakers in the public comment section.  The commenters emphasized that EMA is an important concept and the countermeasures are definitely different from Food Safety and even Food Defense.

    • Why “Disgruntled Employees” Not In This Rule:  FDA reiterated their belief that the intent of a “Disgruntled employee” is not to inflict a large public health harm.  As applies also to EMA, they stated that “Congress directed us to prioritize risks” and “We think [the rule defined this way] was what congress was directing us to do.”  Also, an interesting point made is that the FDA Food Defense countermeasure (FDA Food Defense Plan Builder, CARVER+Shock, etc.) is  focused on a “sophisticated insider” and a disgruntled employee would most likely be an “unsophisticated insider.”
    • Why “EMA” Not In This Rule:  A question was “…does FDA believe they have the leeway to move that [EMA] into preventative controls?”  The commenter mentioned that FSMA states “intentional adulteration, including acts of terrorism” (note the comma) and this proposed rule states intentional adulteration caused by acts of terrorism” (note only terrorism).  FDA reiterated that this is appropriate since this section of FSMA outlines a focus on “high risk foods.”  Several sections of FSMA do open with text mentioning that the leadership can set the focus or, as stated, aspects that “the secretary feels are important”.  FDA mentioned that they were very eager to get comments on EMA – they have several very direct requests for comments.

    FDA’s direction on the “Intentional Adulteration” section clearly shifts the FDA Food Defense focus from all “intentional contamination” back to traditional Food Defense that was defined under Homeland Security Presidential Directive-7 and -9 (terrorist attacks).  There is no ambiguity on the direction for the FDA Food Defense team.  How and where EMA will be addressed is still to be determined.  Thus, there couldn’t be a more important time to be involved in Food Fraud.  Keep following the FDA direction and activities.  Definitely consider submitting your formal comments to FDA. The due date is March 31, 2014 and you can access the system here: see Docket No. FDA-2013-N-1425 on  http://www.regulations.gov.   JWS.

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