What will FDA consider a Food Fraud “Known or Reasonably Foreseeable Hazard” and a “Pattern”? Is it one (1) known incident, one in a million or billion transactions? This is a—THE—critical compliance question for the Preventative Controls section of the Food Safety Modernization Act (FSMA-PC). At what point is there legal liability or even criminal liability. Answer: To Be Determined, and hopefully not in court applied to you.
This is a presentation of our preliminary results for the survey research we announced during our two Food Fraud sessions at the 2015 Food Safety Summit [1-2]. We also posted this on our website and emailed it to our contact list. Our goal was 100 expert surveys and we achieved that in ten days.
The manuscript is currently “Under Review” at a high impact factor food scholarly journal . From the Abstract:
“This survey of Food Fraud experts provides a foundation for understanding how the likelihood and consequence of a Food Fraud event are assessed. The survey also explores how Food Fraud prevention strategies are scoped, as well as how experts perceive the role of government in prevention. Specifically, we examine the role of the US Food and Drug Administration fraud mitigation strategies based on the powers granted in the Food Safety Modernization Act. This includes the subjects of “reasonably foreseeable hazard” and “reasonably likely to occur. To challenge the way Food Fraud is assessed there were comparisons to a non-food incident (the Germanwings airline intentional crash by a suicidal pilot) and the common food safety risk of pesticide residue contamination.”
A month before this survey in March 2015, the Germanwings airplane traveling from Barcelona to Dusseldorf was intentionally crashed by a suicidal pilot, killing all 150 passengers. Immediately after that incident airlines put very high profile and visible countermeasures in place. This was a current and very concerning risk for our travel-intensive survey population so it was an excellent case study to examine their risk assessment process .
(I personally noticed a heightened vigilance when the pre-flight announcements made very clear the new policies to keep the forward bulkhead clear. Also, on my flight back from Bilbao, I stood up to stretch my legs and I noticed the forward area blocked by a beverage cart across the aisle. When I looked up one of the pilots was also there and very urgently and somewhat aggressively instructed me to SIT DOWN. Wow… definitely a heightened awareness.)
To assess suicidal pilot incidents:
- There were reports of at least five (5) know suicidal pilot crashes in 23 years.
- Of those incidents, there were 422 deaths—84 deaths per incident and 18 deaths per year.
- Over the 23 years there were an estimated 250 million flights.
- the US Department of Transportation estimates about 28,000 flights per day or 10 million flights per year in the US alone, so if the five (5) incidents occurring in the US that would equate to a probability of 0.0002% per day.
From our MSU Food Fraud Initiative Report on the Preventative Controls Rule , we explore a broad and narrow interpretation of each line of text related to Food Fraud or Economically Motivated Adulteration (FF/EMA). From FSMA-PC:
“[Per the FSMA-PC, FDA does] continue to believe that hazards that may be intentionally introduced for economic gain will need preventive controls in rare circumstances, usually in cases where there has been a pattern of economically motivated adulteration in the past.”
“Such hazards will be identified in rare circumstances, usually in cases where there has been a pattern of economically motivated adulteration in the past. In addition, we define hazards to only include those agents that have the potential to cause illness or injury.”
Technically the text seems to provide a lot of leeway for interpretation, but before debating this point too long, consider that compliance with GFSI (including the new Food Fraud aspects) will probably cover the broad interpretation FSMA-PC regarding FF/EMA:
- “Economically Motivated Adulteration” and “hazards” must be addressed.
- EMA is not defined and the previous working definition from the Federal Register notice is not cited. The scope of EMA is not explicitly defined as only adulterant-substances. Is an “agent” an intentionally added “adulterant-substance”?
- An “agent” is not defined. This does not explicitly exclude broad Food Fraud incidents such as stolen goods that become spoiled that are sold for economic gain.
- “Known or Reasonably Foreseeable Hazard” must have a “preventative control.” There is no defined threshold for what “hazards” must be addressed or what is an acceptable “mitigation plan.”
- Though a new FDA rule, it appears FSMA-PC compliance is achieved by meeting the most basic GFSI Food Fraud requirements.
Applying the Risk Assessment Findings to FSMA-PC
To further understand what might be a “known or reasonably foreseeable hazard” for FSMA-PC, are the five (5) known incidents:
- a “known or reasonably foreseeable hazard”?
- a “pattern”?
Is it a consideration that:
- these five incidents occurred over 23 years?
- these five incident occurred over 250 million transaction?
- the adverse health effect is 100% death and the average is at least 100 per incident
- the US FDA Carver+Shock Food Defense tool would probably rank a 3/10 due to “Loss of life less than 100. Small impact on sensitive subpopulations, e.g., children or elderly. National economic impact between $100 million and $1 billion.”
The objective of regulatory compliance hangs in the balance. The final application of this law will be seemingly defined by actual incidents and in court. The preliminary results from our survey research project further define the ambiguity.
To apply “critical thinking” theory, it is good to step back and consider the big picture. Conducting a Food Fraud Vulnerability Assessment — addressing all types of incidents, not just adulterant-substances — and implementing a Food Fraud Mitigation Plan will be required for GFSI compliance. Many Food Safety Management System scheme owners are requiring compliance now. So the FSMA-PC compliance nuance may be a moot point if the letter and spirit of FSMA and FSMA-PC is addressed by the new industry certification. To be proactive, begin addressing all Food Fraud. Consider the resources on our website, our free Food Fraud MOOC, or the instruction in our Executive Education programs. FFI.
- Spink, J (2015). German Wings Airplane Crash: Was it a ‘Reasonably Foreseeable Hazard’ or ‘Reasonably Likely to Occur,’ Blog Post, March 31, 2015, URL: FoodFraud.msu.edu
- Spink, J (2015a). Survey – Food Fraud Prevention Survey at the Food Safety Summit 2015, Blog Post, April 28, 2015, URL: FoodFraud.msu.edu
- Spink, J & Moyer, DC (2015). TITLE, MSU Food Fraud Initiative Report, URL: http://foodfraud.msu.edu/2015/10/08/review-final-rule-for-fsma-preventative-controls-regarding-food-fraud-and-ema-see-15-page-preliminary-report/
- Spink, J, Speier-Pero, C, and Fenoff R. (Under Review). A review of the methods and data used to rank Food Fraud Risks including public policy recommendations for the US FDA – A Survey. [Affiliations: Speier-Pero, PhD, is a Professor in the MSU Broad College of Business and Professor Fenoff, PhD, is an Assistant Professor at The Citadel Department of Criminology.]