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TAG June 15, 2017 0 Comments

Would you like to know how many plants FDA has taken environmental samples from? Perhaps you’re wondering how many were positive? Or what FDA did with its samples? FDA is now publicly publishing that information, and tracking it month to month. In 2016, FDA released its 10-year strategic plan defining and discussing the four key goals of the Foods and Veterinary Medicine Program including Food Safety, Nutrition, Animal Health, and Organizational Excellence, and related objectives for fiscal years 2016-2025. While there are, undoubtedly, a number of industry folks who read, or at least scanned, the document to determine where the agency would be putting its focus, I would wager that there are even more who did not wade through the 30-page document. But whether you did or did not take the time to do so, it would definitely be worth your while to take a look at the updated FDA-TRACK website which FDA developed – and recently updated – to track the performance measures and key projects by strategic goal, strategic objective, program area, and initiative. FDA’s purpose was to provide a comprehensive and cross-cutting view of progress on the four Public Health Outcomes of its strategic plan: Reduce the incidence of illnesses and deaths attributable to preventable contamination of FDA-regulated food and feed products. Reduce risk factors for and the incidence of nutrition-related chronic disease. Reduce human and animal illness and death from FDA-regulated animal health products. Enable the FVM program to optimize public health gains by making the best use of available resources. While this is interesting and important, what will likely really grab your attention, as it did mine, is that of the statistic and tables of that “progress,” particularly that of goal #1. For example, according to the data on the site: Since October 2016, FDA has taken environmental samples from 231 firms. It averaged 42 firms per month, except December 2016, when it took samples from only 19. Of this total, 1/4 (57) of the firms had positive environmental samples, with a total of 224 positive samples taken. However, these resulted in only 14 recall recommendations entered in the Recall Enterprise System (RES) and 2 domestic compliance actions (warning letters, injunctions, seizures), due in part to sampling location. FDA includes information on its adding of positive findings to the Whole Genome Sequencing (WGS) database. Of the 197 findings added, 30 were a clinical match to a known foodborne illness pathogen – which led to 10 of the recall recommendations and 2 to the domestic compliance actions. Other interesting information According to the data, 97% of FDA inspectors have been trained on new preventive controls for human food regulation and are conducting inspections against the Preventive Controls for Human Food regulation. 4% of state regulators have undergone the training and are conducting these inspections. 43% of those in the U.S. food industry, who are subject the PC rule, have successfully completed training conducted by FDA, funded by FDA or using FDA-recognized curricula. What does all this mean? It means that FDA regulators have been trained; they are doing preventive controls inspections; they are taking samples; and they are using the WGS database. And food facilities are being held liable for positive findings. We have repeatedly discussed the importance of a good environmental control program and clearly the statistics discussed above further support that strategy.  It is clear to me that FDA are on a variety of missions to protect public health.  The number of “swabathons” is significant and as noted above these are not without consequences. So keep asking yourself if you ready for FDA sampling in your facility? About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance.


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