This month, the U.S. Food and Drug Administration revealed plans to restart “prioritized domestic inspections” during the week of July 20th. The agency plans to resume inspections based on COVID-19’s curve in a particular state and locality, as well as whatever the guidelines the state and local governments have in place.
For FDA officials to decide safe locations for these inspections, the agency designed a rating system built on real-time data and qualitative assessments of COVID-19 cases by geography. The COVID-19 Advisory Rating system data is available to individuals who conduct inspections of FDA-regulated entities on the agency’s behalf.
“The Advisory Level is based upon the outcome of three metrics: Phase of the State and statistics measured at the county level to gauge the trend and intensity of infection,” FDA’s Commissioner of Food and Drugs Dr. Stephen M. Hahn explained in announcing the new system. “When each of these is taken into consideration, the FDA will identify regulatory activities that can occur within the given geographic region. The three main categories of regulatory activity at the county level will be: mission-critical inspections only, all inspections with caveats to help protect staff who have self-identified as being in a vulnerable population, and resumption of all regulatory activities.”
Except for retail tobacco inspections, FDA officials decided that, for now, they will announce prioritized domestic inspections in advance, which will help ensure the safety of all involved personnel, while also providing that suitable staff are on-site to support the audit.
Additionally, on July 13, 2020, the FDA unveiled a “blueprint” for a strategy to enforce a “New Era of Smarter Food Safety.”
“The blueprint outlines a path forward that builds on the work the FDA has already done through the implementation of the FDA Food Safety Modernization Act (FSMA),” Hahn said. “FSMA has been a centerpiece of our work to ensure food safety and prevent foodborne illnesses through the use of science and risk-based standards. The authority granted by FSMA enables a flexible framework that is adaptable to the changing food environment as science and technologies evolve.”
The agency drafted this new proposal based on “four core elements:”
Tech-enabled traceability: Widespread traceability delivers greater supply chain visibility, helping the FDA and food industry stakeholders prepare for the kind of imbalances in the marketplace that led to temporary shortages of certain commodities and created food waste when producers lost customers because restaurants, schools, and other sites temporarily closed. Enhanced traceability, coupled with advanced analytical tools, can identify potential problems and help mitigate their impact.
Smarter Tools and Approaches for Prevention and Outbreak Response: One of the most valuable resources the industry has at its disposal is the ability to unleash the power of data. The FDA plans to do everything it can to “attain better quality data, conduct a more meaningful analysis of it, and transform streams of data into more meaningful, strategic, and prevention-oriented actions.” This includes strengthening the agency’s procedures and protocols for conducting the root cause analyses to identify how a food product became contaminated and inform its understanding of how to help prevent that from happening again.
New Business Models and Retail Modernization: The FDA is also looking at new business models to produce and deliver food. In recent years, groceries and meals have increasingly been ordered online and delivered directly to consumers. In the past few months, however, as consumers have heeded stay-at-home recommendations and ordered their food online from restaurants and supermarkets, this trend has skyrocketed. Hahn said the agency “must help ensure that as these foods travel to our front doors, they continue to be safe for consumers.”
Food Safety Culture: The pandemic has forced everyone to re-examine what we mean by “food safety culture.” It’s more important than ever to do more to influence and change human behavior, as well as to address how employees think about food safety, and how they demonstrate their commitment to this as part of their jobs. But an influential culture of food safety involves more than food safety culture, it’s also about keeping food workers safe and educating consumers on safe food handling practices.
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