Area hospitals in Chicago see a string of illnesses due to E coli O157, with more cases quickly popping up across the state. A look into the sick patients’ activities reveals they all ate sprouts at a popular sandwich chain, triggering an investigation down the supply chain.
It isn’t long till the Food and Drug Administration is knocking on the door of the sprout supplier, telling company officials they have 24 hours to turn over a year’s worth of records for the outbreak investigation.
This fictitious outbreak scenario is not an unlikely one, given the propensity for fresh sprouts to be contaminated with E. coli, Listeria and Salmonella. But all food companies, not just those handling items designated as high risk foods, can relate to the frightening nature of the records request by the FDA. Such requests are fact, not fiction under the Food Safety Modernization Act (FSMA) and its congressionally mandated rules.
One of the (FSMA) rules gives FDA the authority to demand two years of records in the event of “reasonable belief” that food is affected and is a risk to human or animal health — with failure to do so potentially resulting in a civil and criminal penalties.
Officials with the FDA say information required for records varies according to the rule, which includes multiple categories for businesses. Given this, the dirty details must be hashed out individually by each business.
However, Jim Gorny, vice president for food safety and technology for the Produce Marketing Association, says detailed record keeping is essential to good business management regardless of FSMA requirements.
“Record keeping is important in that it helps companies know what they’re doing when the FDA is not physically present. If they come under inspection, they can look back and see that what happened today has not only happened today, but also prior to the inspection date for some period of time,” Gorny said.
“A lot of these are operational records which will be used to run the enterprise. They are actually management tools that help managers, partners and operators know what is going in their business, particularly when business get large beyond a sole proprietor. A large enterprise requires a lot of people and the only way you can keep track of that is through paperwork because you can’t be physically present all the time at all places. The records required are key pieces that truly relate to food safety.”
One thing remains the same across the board under FSMA, and that is the option to provide records in a hardcopy or digital format, as long as they are in a legible and organized form.
Think back to the sprout outbreak scenario: While a food safety outbreak investigation is in motion, everyday business still needs to be attended to and the FDA hands out a tight timeline for mountains of detailed information that can mean the difference between getting the situation resolved quickly or being hit with court action.
Now imagine sorting through all the needed records by hand in file cabinets, and again by a short amount of time behind a desk, pulling files from a food industry record keeping computer program.
“Companies today use numerous ways to deal with paperwork. Some are still using pen and paper, and others are using electronic records more and more frequently,” said Gorny.
“Electronic records offer the ability to regulate the data, sort through big data and are better at managing the information that you get into a usable form.”
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