In 1985, sweet white dessert wines imported from Austria were recalled in the U.S. and other countries due to adulteration with the chemical diethylene glycol (DEG). The addition of small quantities of DEG allowed the continuous production of desirable wines of a consistently high quality without causing short-term health effects in consumers. Ultimately, the adulteration was discovered by a tax inspector who investigated the tax records of a winery. This incident illustrates two of the biggest challenges of preventing EMA. The first is that perpetrators—in this case, a chemist—are intelligent adversaries that may have the technical expertise to effectively evade quality assurance and regulatory testing programs. The second challenge illustrated by this incident is that the most successful adulterant is the unexpected adulterant. At the time of the Austrian wine incident, there was no reason to expect the presence of DEG in wine and no testing was being done for this adulterant.
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For all these reasons, food companies that want to proactively address the risk of EMA in food ingredients that they source need to go above and beyond what is currently outlined in the proposed rule on preventive controls in the recently-released update to the Food Safety Modernization Act (FSMA). In the “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food” proposed rule, FDA indicated that additional requirements surrounding EMA would best be addressed as part of preventive controls efforts. The regulations as proposed would focus on “circumstances where there has been a pattern of adulteration in the past” and adulterants that are most likely to cause illness. Relying only on these factors would likely not have prevented the tragic melamine incident of 2008 given the lack of historical information about melamine adulteration of dairy products that was available at the time. There is general consensus among many organizations that effective mitigation of EMA requires a vulnerability assessment type of approach that holistically considers several contributing factors that underlie the opportunity and incentive for perpetrating EMA instead of just focusing on historical incidents. The GFSI Food Fraud Think Tank recommends the food industry conduct vulnerability assessments and subsequently put in place appropriate control measures.
On Nov. 17, 2014, USP, a scientific standards-setting organization that develops quality standards for medicines, food ingredients, and dietary supplements, issued the first publicly-available draft guidance on conducting EMA vulnerability assessments. The draft guidance for mitigating EMA risk was designed to be generally applicable to any food ingredient, and any food fraud management system that can be developed from this framework should be viewed as a dynamic and continuous process. The guidance includes an assessment of the contributing factors to EMA vulnerability, which can then be ranked on a low-to-high scale for vulnerability (see Table 1). Each of these contributing factors is discussed briefly below.
EMA/Food Fraud History. One of the most basic indicators of EMA vulnerability in a particular food product or ingredient is its EMA history and pattern. Information about EMA incidents and issues can be found in the NCFPD EMA Incidents Database and USP’s Food Fraud Database.
Supply Chain Structure. Visibility and control along supply chains can mitigate EMA vulnerability. The degree of vertical integration, oversight, and traceability should all be considered as part of a vulnerability assessment.
Supplier Relationships and History of Quality/Safety Issues. In addition to the structure of supply chains, the degree to which an established and trusted relationship has been formed with ingredient suppliers and the history of food quality and safety issues among those suppliers can provide insight into the potential for EMA vulnerability.