After a few months’ delay caused by the COVID-19 pandemic, FDA released its blueprint for adapting to ongoing and anticipated changes in the food system, titled New Era of Smarter Food Safety: FDA’s Blueprint for the Future. The blueprint is the result of discussions that have been underway since last year, and FDA describes it as a work in progress that is subject to change. Nonetheless, the four “core elements” identified by FDA seem likely to remain central to the agency’s strategy for enhancing foodborne illness prevention and response. Those elements are:
- Tech-enabled traceability – FDA’s ultimate goal is “to have end-to-end traceability throughout the food safety system.” To that end, FDA seeks to foster development of “foundational components” (e.g., adoption of existing consensus standards), encourage industry to adopt new technologies, and leverage “the digital transformation” (e.g., potential internal implementation of blockchain). FDA flags as its first step the completion of rulemaking under section 204 of the Food Safety Modernization Act “to harmonize the key data elements and critical tracking events needed for enhanced traceability.”
- Smarter tools and approaches for prevention and outbreak response – FDA seeks to harness new data streams to “enhance and strengthen root cause analysis and predictive analytics” so as to minimize identified risks, optimize use of resources, and maximize the agency’s “food safety reach.” Specific goals identified in the blueprint include invigoration of root cause analysis; strengthening of capabilities in predictive analytics (e.g., expanded use of artificial intelligence for activities such as screening imported foods); strengthening of mutual reliance with regulatory partners; implementation of additional tools for inspections, training, and compliance (e.g., use of remote/virtual inspections); enhancing response to outbreaks of foodborne illness; and modernization of recalls (e.g., develop guidance on consumer notification).
- New business models and retail modernization – New models of food production and delivery – and continuing risks associated with existing models – are prompting a fresh look at how best to protect against contamination. FDA seeks to ensure food safety as new models are implemented (e.g., home delivery), and modernize retail food safety.
- Food safety culture – The blueprint posits that the burden of foodborne illness cannot be dramatically reduced without behavioral changes. FDA thus seeks to “promote food safety culture throughout the food system” (including among consumers); promote food safety culture throughout FDA itself (e.g., by potentially factoring food safety culture into the frequency of inspections); and educate consumers on the importance of food safety.
In FDA’s view, the experiences of the COVID-19 pandemic only highlighted the need for the blueprint and the need to modernize FDA’s approach – from “unprecedented imbalances in the marketplace, to changing consumer behaviors and a rise in e-commerce, to challenges to performing inspection and compliance work in FDA’s traditional manner.”
FDA has appointed some familiar senior food staff as team leaders for each of these core elements, who will “help to identify the short and long-term actions to fulfill the goals laid out in the blueprint over the next decade, working in partnership with stakeholders.” In the context of that partnership, the agency may find itself working through thorny questions regarding the limits of its statutory authority, and confronting significant internal and external resource limitations that could hamper the fulfillment of its vision. Given the agency’s description of that vision as a “sea change,” those who haven’t been paying attention and have a stake in the outcome might want to start tuning in.