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.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.
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FDA’s October 2019 public meeting covered the topics below in great detail. The agency and stakeholders identified possible technologies that are being used to solve food safety problems.
Foodborne outbreak response
FSMA rules regarding traceability promoted the concept of a one-step-forward and one-step-back protocol that basically had its origins in the Bioterrorism Act of 2002. Although FSMA has added some refinements to recordkeeping rules, current traceability systems are often less than accurate, are limited in scope, and can be untimely in a recall situation. With many food companies still utilizing paper-based recordkeeping systems, there is an opportunity to enable digital systems that promote full traceability. The use of new and evolving digital technologies envisioned in the new era program could play a pivotal role in tracing the origin of a contaminated food to its source in perhaps minutes, instead of days or weeks. End-to-end traceability of contaminated food is a food safety issue that may be solved using new technologies. In the new era, when health problems are identified, technology may have a role in providing data to enhance responses to foodborne outbreaks and enhance communications about outbreaks resulting in more efficient recalls and enhanced public safety.
Smarter tools and approaches for prevention
Prevention is a key concept in FSMA’s food safety plans. The hazard identification process used in developing an effective food safety system is often the most difficult step in designing a comprehensive plan. The workshop addressed several opportunities, including looking at new tools and new technologies, improving existing processes, and enhancing communications on illness trends and potential food safety concerns. Artificial intelligence may have a role in predictive analysis as well as enhancing current sampling and inspection strategies.
New business models and retail modernization
Believe it or not, retail sales may be looking backward and forward at the same time. From about the 1780s up until the 1950s and 1960s, milkmen delivered milk to homes all across the country. Products like milk, eggs, and other perishable food products were delivered door to door until home refrigeration and local grocery shopping became popular. Today, all kinds of products are delivered to our doors, including online shopping packages, groceries, restaurant/fast-food takeout meals, diet meals, and ready-to-prepare upscale meals in a box. This food convenience trend brings about new food safety issues that warrants looking at possible vulnerabilities and gaps in food safety from seller to consumer. A partnership with the e-commerce community on food safety, food delivery, and safe food transportation may also be warranted.
Food safety culture
The need for CPG companies to embrace a food safety culture was not disputed in the breakout sessions. However, its definition was debated. The jury is still out on a good definition, but I believe there are three important aspects to this important concept. First, management must embrace the importance of food safety and set an example. Next, training is paramount to ensure staff understands the importance of food safety and exactly what the staff’s role is to ensure public safety. Finally, there must be routine updates and reminders of food safety’s importance, so employees don’t take shortcuts or become complacent in sanitation and hazard prevention tasks.
References
Federal Register, 2015. Current Good Manufacturing Practice. Hazard Analysis and Risk-based Preventive Controls for Human Food. Vol. 80, Sept. 17. 55908.
Barach, J., 2017. FSMA and Food Safety Systems: Understanding and Implementing the Rules. John Wiley & Sons, Ltd. West Sussex, U.K.
Federal Register, 2019. A New Era of Smarter Food Safety; Public Meeting. Food and Drug Administration. Request for Comments. Vol. 84 (181) Sept. 18. 49112.
Fontanazza, M., 2019. FDA Receives Record Turnout as Industry Eager to Discuss New Era of Smarter Food Safety. Oct. 22. See link at: https://foodsafetytech.com/news_article.
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