Food Fraud Vulnerability Assessment and
Prefilter for FSMA, GFSI and SOX Requirements
Have you completed your food fraud vulner- ability assessment (FFVA) for all types of fraud and all your incoming and outgoing prod- ucts? For the Food Safety Modernization Act
(FSMA), you must address all types of food
fraud and identify and address “hazards that
require a preventive control.” This article presents recent peer-reviewed research on methods
to comply with FSMA, the Global Food Safety Initiative
(GFSI) and other food safety requirements and initiatives.
Food Fraud Scope
Food fraud is illegal deception for economic gain using
food, including economically motivated adulteration (EMA)
defined by the U.S. Food and Drug Administration (FDA) to
be a “substance” for “economic gain.” FSMA has been less
clear on the terminology since the Preventive Controls-Qual-
ified Individual training added new terms of “economically
motivated hazard” and “economically motivated food safety
hazard.” The general types of food fraud
include adulterant substances, theft, tamper-
ing, simulation, diversion or gray market, and
intellectual property rights counterfeiting.
Compliance History and
Requirements
Although FDA’s current focus is on FSMA,
there are several compliance requirements that address all
types of global food fraud (Table 1). While strict liability and
the Park Doctrine have been in effect, there is a new emphasis
on criminal liability for the individuals, not just the company. The
FDA Office of Criminal Investigation and the U.S. Depart-
ment of Justice have publicly stated there will be a focus on
criminal prosecution for the corporations as well as the indi-
vidual.
FSMA Preventive Controls rule: As of September 2016, one
significant compliance requirement is for vulnerability as-
sessments that address all types of food fraud, specifically, all
The scope of
responsibility
and methods for
compliance
