EMA Strategy

Identifying Vulnerabilities Through a Historical or Predictive Approach

Dried oregano bulked out with olive leaves. Melamine added to baby formula and pet food. Asian catfish sold as grouper. Ground horse meat mixed into ground beef. Pomegranate juice cut with grape juice. Common honey sold as Manuka honey. Lead chromate used to color turmeric…. Unfortunately, economically motivated adulteration (EMA) instances such as these are not uncommon.

EMA, also called food fraud, is the act of defrauding buyers of food or ingredients for economic gain. It has been an issue of concern for food manufacturers, retailers, and importers for some time. In fact, food fraud is as old as the practice of selling or bartering food, and many of today’s laws around the world have their origins in addressing some form of food fraud. Individuals who are involved in the practice of EMA try to turn a profit through a variety of methods, including unapproved enhancements, dilution with a lesser-value ingredient, concealment of damage or contamination, mislabeling of a product or ingredient, substitution of a lesser-value ingredient, or failure to disclose required product information.

Typically, the intent is economic, not meant to cause harm. This is, at least in part, because the fraudster can continue to profit as long as people remain deceived; if there are ill effects, the fraud may be revealed, putting an end to the profits.

However, in attempting to substitute, dilute, etc., the perpetrator may unknowingly add a harmful substance in lieu of the authentic food ingredient. There are cases where a fraudulent act has led to illness or death. In one well-known case in China, melamine was added to infant formula to raise the measured level of protein content. This adulteration inadvertently sickened thousands of babies and resulted in several deaths. A similar incident occurred in the U.S., when wheat gluten in pet food was diluted with melamine and cyanuric acid, resulting in illness and death for hundreds of pets.

Economically motivated adulteration is illegal. Ingredients must be truthfully and accurately disclosed on a label, and consumers have a right to get what they pay for. But generally this type of adulteration does not take place at the point of final food manufacturing. Rather, gaps earlier in the supply chain may provide fraudsters with an opportunity to introduce their sub-standard products.

What is the responsibility of food manufacturers to understand their supply chains and vulnerabilities therein? FDA’s rule to protect food against intentional adulteration (the food defense rule) is limited to those situations where the objective of the adulteration is to cause public harm. As previously noted, EMA is very different in that, although intentional, harm is not the intent. Thus, addressing EMA is outside the scope of the food defense rule. However, FDA’s Preventive Controls regulations, both for human food and for animal food, which go into effect for many facilities in September 2016, will now require manufacturers to consider food safety hazards that may be intentionally introduced for purposes of economic gain (i.e., EMA).

FDA suggests that facilities rely on historical incidents to identify potential EMA vulnerabilities. But this is not the proactive approach that industry would like to take. Instead, the industry has concluded it is far better to understand how and why known EMA issues have previously occurred, and use those insights to predict the susceptibility ofingredients.

Partnering with Battelle R&D, GMA has developed a risk assessment tool to assist manufacturers in allocating their resources to areas within their supply chain that are the most vulnerable. EMAlert brings together continuously updated commodity-attribute data combined with user input to produce quantitative vulnerability results, providing users with the information necessary to effectively prioritize mitigation efforts associated with EMA threats. EMAlert provides manufacturers with an effective, easy-to-use resource to assist with the requirements of this regulation.

Economically motivated adulteration is a serious issue for the food industry. Manufacturers are increasingly gaining visibility through their supply chains, and are employing the best practices and the latest technologies to help ensure the continued integrity and safety of our global food supply chain.

The author is GMA manager, food safety and quality assurance.

July 2016
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