The Food Safety Modernization Act (FSMA) in the U.S. continues to be the talk of the food and beverage industry these days. But what seems to be lost in all the talk is that U.S. regulations and requirements—even if/when the Act is fully rolled out—will still be less strict than those of Europe. For more than a decade, European authorities and producers have been held to higher standards for food quality than any other region worldwide, and the results have matched the regulation: Europe has one of the lowest levels of food contamination in the world.
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Explore This IssueAugust/September 2013
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What makes Europe’s success so remarkable is how complex the system is: Despite strict regulations enforced to protect more than 500 million people, compliance takes place without interfering with the independence of the EU’s 27 sovereign nations. Such a structure would be impossible without a massive technology infrastructure and investment in state-of-the-art data management technologies, including laboratory information management systems (LIMS), which are widely used by industry and governments to structure laboratory sampling, analysis, and reporting tasks and integrate food quality data across vast enterprise systems.
What Makes Europe Different?
Europe has had its share of safety issues. Several food crises, including outbreaks of mad cow disease (formally known as Bovine Spongiform Encephalopathy or BSE), Salmonella, and botulism, led to the establishment of the European Food Safety Authority (EFSA) in 2002. The organization’s mission is straightforward, but ambitious: “To deliver independent, high-quality, and timely scientific advice on risks in the food chain from farm to fork in an integrated manner and to communicate on those risks in an open manner to all interested parties and the public at large.”
If achieving this goal wasn’t challenging enough, EFSA must do all this while respecting the sovereignty of the EU’s member states. The dramatic rise in international trade over the last 20 years, coupled with increasingly complex supply chains in food manufacturing, means that new rules must be all-encompassing without being stifling. While Europe needed stricter regulations in 2002, the EFSA had to promulgate them in concert with the food safety authorities of individual nations within the EU.
According to its website, “to ensure the high quality of its work, EFSA has developed guidance on methodologies for the risk assessment and the risk monitoring it undertakes.” The same law that established the EFSA—Regulation EC/178/2002—laid the groundwork for implementation guidelines, principles, and procedures. For example, any food produced in Europe or imported is now subject to some of the strictest traceability requirements in the world. The regulation requires that manufacturers and distributers have “the ability to trace and follow food, feed, and ingredients through all stages of production, processing, and distribution.”
Since the rules apply to imported food as well, companies based in the U.S. and other non-European nations must comply if they wish to continue selling in Europe. This means that for a candy bar to be shelved in a Paris grocery store, its Illinois-based candy manufacturer must be able to identify which North Carolina farm grew the peanuts inside the bar.
To date, the EFSA’s massive undertaking is working. The organization cooperates with more than 400 organizations within the EU to carry out food testing, and since 2002 the EFSA has published more than 2,500 “scientific outputs”—pieces of research used to institute new regulations or modify existing rules. The number of cases of BSE has fallen from thousands each year before the institution of the EFSA to only 44 in 2010, and now only two percent of EU residents consider mad cow to be a possible food risk. Salmonella contamination has fallen off even more dramatically, decreasing by 50 percent from 2004 to 2009.
One of the key contributors to successful monitoring of food safety from farm to fork is the application of consistent practices to the laboratory environment. Since 2010, the EFSA has required that laboratories generating data that will be used as a part of any traceability record must be accredited under the ISO/IEC Standard 17025: General requirements for the competence of testing and calibration laboratories. The ISO 17025 standard defines a series of requirements around technical competence and continuous improvement, which demand that labs keep records not just of the samples tested and their results, but of supporting data such as instrument calibration status, staff training records, reagents and standards, etc. Having this universal accreditation requirement for all food-related analysis meansit’s possible to compare data sets from different sources, which in turn leads to faster and more accurate monitoring of food-related incidents that may impact EU citizens.
LIMS Plays a Star Role
As well thought-out as the EFSA approach is, the system would be impossible to administer without sophisticated data management, like today’s enterprise-level LIMS. From 400 independent organizations, individual manufacturers, and national authorities within the member states to the EFSA itself, the massive sampling operation hinges on consistent, reliable laboratory testing, management, and integration. LIMS monitor instrument calibration and maintenance schedules ensure proper training records for personnel, manage workflow and testing requirements inside labs, and store all records related to sample testing and report generation. A LIMS also provides a secure data management environment for monitoring batch relationships between raw materials, processed materials, and packaged goods in an increasingly complex food supply chain. Having a LIMS also ensures the external accreditation program for ISO 17025 is significantly less burdensome for the laboratory by having online searchable access to supporting records—something that is both time consuming and tricky if the data is kept as paper records.
Across many individual labs, LIMS technology aggregates and analyzes the massive data sets throughout Europe, helping authorities identify potential outbreaks before they happen.
Navigating and thriving in a system as complex as the EFSA’s requires more than instinct and hands-on experience. With LIMS behind the scenes automating data aggregation and analysis, equipment calibration and maintenance, technician training, and more, the global players in the food supply chain are united in a common goal: Ensuring that everything we eat and drink is tasty, nutritious, and, most important, safe.
Thurston is the director of product strategy for process industries at Thermo Fisher Scientific, and is responsible for determining the strategy of Thermo Fisher’s current informatics portfolio while identifying new market opportunities within the process industry sector.