FDA’s New Era of Smarter Food Safety

The agency’s vision is based on three fundamental tenets: It must be people-led; it should be FSMA-based; and solutions should be technology-enabled.

Smarter Food Safety
Source: Presentation at FDA’s Public Meeting on Oct. 21, 2019; A New Era of Smarter Food Safety by Frank Yiannas, FDA deputy commissioner for food policy and response.

It has been almost five years since the Food and Drug Administration (FDA) developed rules and guidance for the Food Safety Modernization Act (FSMA) of 2011. This comprehensive and globalized food safety approach was intended to replace the regulatory implementation directive for the basic tenets of the hazard analysis critical control point (HACCP) food safety system.

FSMA developers recognized that current consumer packaged goods (CPG) companies were complex, and for food safety principles to work well, a farm-to-fork approach was needed as well as a reach overseas for assurances that suppliers were practicing the same food safety rules mandated in the U.S. Consequently, the human food rules in FSMA (Barach, 2017) were expanded to address foreign-made food, produce food safety, and incorporate practices to prevent intentional adulteration and ensure food security. 

With these past major advancements and comprehensive steps to develop a truly global food safety system approach, it is fair to ask, what does FDA need and expect beyond FSMA? In both HACCP and FSMA programs, food safety plans were to be periodically reviewed and updated because FDA and plan developers anticipated that technology advances were inevitable, and that new emerging pathogens and processing practices would present new challenges to previous food safety programs. Changes in technology, pathogens, and processing are the driving factors behind FDA’s awareness that we are entering into a new era of smarter food safety, indicating that perhaps we should re-evaluate the use of new innovations to improve it.

Food safety expert Jeffrey T. Barach says FDA plans to develop a global food safety system by leveraging advanced technologies and embracing input from the public sector.Food safety expert Jeffrey T. Barach says FDA plans to develop a global food safety system by leveraging advanced technologies and embracing input from the public sector.The initiative behind FDA’s new era program can be summarized by this core question: What food safety problems are not being addressed by current technology and FSMA regulations that new and developing technologies can help solve? FDA has been careful to explain that the directive here is not just to find applications for new technologies for the sake of implementing that novel technology. The agency and others assert that there must be a definitive match between the problem to be solved and a proposed new technology. All agree that using a business-critical, decision-making process that shows the new technology as a compelling solution is paramount.

Because the development, adoption, and implementation of smarter food safety solutions will involve both the agency and food companies, FDA recognized early on that significant input must come from the public sector. In April 2019, FDA released a joint statement on the New Era of Smarter Food Safety (Fed. Reg., 2019) and called for a public meeting on Oct. 21, 2019. FDA said this new initiative was intended to build on FSMA by leveraging new and emerging technologies as well as new approaches to help solve some of the biggest food safety challenges. The public meeting was the first step toward developing a blueprint that will outline critical steps to protect public health and keep pace with the ever-changing global food supply. The blueprint is expected to be available in 2020.  

At the meeting, an expanded vision of the New Era of Smarter Food Safety was presented by FDA’s Deputy Commissioner for Food Policy and Response Frank Yiannas (see graphic).

FDA is making an effort to bring current FSMA food safety practices up to speed within a changing environment of emerging technologies, increasing global food origins and distributions system, as well as the emerging local distribution approaches. The effort will require resources from both the public and private sectors to be successful. For CPG companies to embrace the forthcoming FDA blueprint, there must be manufacturing incentives. Companies will likely use a decision-making process to help them decide the purpose and payback of adopting new technologies.  


Make plans to visit PACK EXPO International in Chicago, November 8-11, to see the latest technologies for food processing and packaging machinery and materials.

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