Deadly contamination outbreak leading to 2 deaths and 141 sickened – Hello FSMA?

According to the Centers for Disease Control and Prevention, since July 7, 2012, two  people have died and 141 have gotten sick after eating cantaloupes that contained salmonella (Wall Street Journal, 8/21/2012). This is the second deadly contamination outbreak in less than a year. Since 1985, 28 people have died from a string of contamination (listeria) outbreaks tied to cantaloupes. When the Food Safety Modernization Act (FSMA) was signed into law by President Obama on January 4, 2011, the rules to implement the law should have been proposed within a year. Food safety advocates believe the FSMA, which includes the first nationwide mandatory safety standards for produce, would have prevented such contamination outbreaks. The law would have required a greater number of federal inspections at farms and food-handling facilities.

The mandates of FSMA would directly affect the food safety and the consuming public in a profound way. The added inspections and mandated processes in place in case of a contamination outbreak would make it easier to recall and block the offensive source of the produce enhancing food safety in the supply chain.

To effectively manage FSMA, from a technical standpoint, FDA needs to define the methods of data capture, processes to follow in case of deviations or findings, and the types of corrective actions and preventive actions a company should fulfill before they are allowed back in the marketplace. Appropriate quality management technology, similar to technology in use today at pharmaceutical and life sciences companies, would be a great starting point.

Food safety is as important as pharmaceutical and medical devices safety, and the technology and software solutions in place for these industries can be easily adopted for the food (produce) sector. An effective farm and food handling facilities audit program, CAPA and data interchange to a central system would allow for easier isolation in case of contamination. It would make it easier for the vendors, distributors and other intermediaries to quarantine and block the offensive source from entering the safe product zone. In addition to the law, there are three other essential things to manage food safety – people, process and technology. FDA already has these in place and recently said that they plan to publish the implementation rules for FSMA ‘soon’.  The question is “will it be soon enough to avoid the next big contamination outbreak?”

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