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FDA’s New Era of Smarter Food Safety Blueprint: Through a Global Lens


By Ritu Nalubola, Letitia Robinson, Katie Serrano, and Vanessa Shaw-Dore


November 12, 2020

From a Global Perspective

In our rapidly evolving and globally connected marketplace, FDA recognizes the need to expand how we approach food safety, as articulated in our recently released New Era of Smarter Food Safety: FDA’s Blueprint for the Future.

OGPS New Era Blueprint Blog

This initiative isn’t only aimed at innovation within the U.S. domestic food safety system. With approximately 13 percent of the U.S. food supply, including 52 percent of the fresh fruit, 29 percent of the vegetables, and 93 percent of the seafood coming from beyond our borders, the blueprint must necessarily incorporate enhanced international outreach and partnerships.

As we all are experiencing the effects of the global COVID-19 pandemic, we realize that the ideas outlined in the blueprint are even more relevant. Ensuring a digital, traceable, and safer food system will help the nations of the world work to maintain a resilient and stable food supply for their consumers.

For nearly a decade we’ve been working to establish and implement the science- and risk-based requirements under the FDA Food Safety Modernization Act (FSMA), which have shifted our focus from responding to preventing foodborne illness.

Now, with our blueprint, we’re building on the progress we’ve made under FSMA by leveraging new technologies, tools, and approaches. The blueprint focuses on four Core Elements, the foundational pillars of the New Era: Tech-Enabled Traceability, Smarter Tools and Approaches for Prevention and Outbreak Response, New Business Models and Retail Modernization, and Food Safety Culture.

Here are key aspects of the blueprint that highlight a global, rather than domestic-only, approach to modernizing our food safety system.

Tech-Enabled Traceability

Traceability is only as strong as the record-keeping system itself and yet today, records involved in moving food through the international supply chain are often still paper-based. Even as some in the food industry have adopted modern traceability systems, these systems are rarely compatible with each other. Thus, when outbreaks occur it can be difficult to rapidly trace the source of contaminated food from point-of-sale back to the farm or food facility. This lack of end-to-end traceability also stands in the way of the transparency needed to better understand the supply chain more generally, particularly during public health crises. Our experience during the COVID-19 pandemic has revealed the importance of having greater supply chain visibility so that FDA and the food industry can anticipate market imbalances that might lead to temporary shortages of some products and the waste of others.

The first step in our effort to establish end-to-end traceability is the recently released food traceability proposed rule that aims to create a standardized approach for tracking certain identified foods throughout the supply chain. This would be done using data elements associated with critical tracking events – growing, receiving, transforming, creating, and shipping. When finalized, the food traceability rule will lay the foundation for industry to adopt, harmonize, and leverage more digital traceability systems in the future.

Tracing technologies are already being explored and used by a growing coalition of large international suppliers and retailers. For example, more than half of the produce industry has implemented traceability processes utilizing technology standards developed by the international organization known as GS1.

That means they use unique identifying numbers for the product, and location numbers at every step of the supply chain.

Through developmental partnerships and dialogue with stakeholders domestically and globally, we anticipate significant achievements on end-to-end traceability. We can help to ensure that the tracing technologies being used by industry work well together by paying attention to issues like interoperability, governance, and common terminology on data elements. FDA also will play a lead role in promoting and participating in traceability governance and harmonization through GS1 and the joint FAO-WHO’s Codex Alimentarius, which sets international food standards, guidelines, and codes of practice for many aspects of the international food trade.

Global Outbreak Tracking

Advances in detection technologies mean that more outbreaks are being detected than would have been possible to detect in the past. Technology already assists outbreak response: whole genome sequencing (WGS) and enhanced analytics allow us to identify illness clusters when they are smaller.

FDA was instrumental in the creation of GenomeTrakr — a global database network that links data generated from organizations around the world and is open to the public for research. Of note, the Latin America Office (LAO) of FDA’s Office of Global Policy and Strategy (OGPS) has played a key role in helping to expand the GenomeTrackr network in that region, through partnerships with laboratories and governments in Mexico, Costa Rica, Argentina, and Chile.

Participating laboratories share WGS analytical data regarding pathogen identification and information about sample collection locations and dates. Mining this data can reveal patterns and anomalies that can characterize the range and virulence for outbreaks of specific pathogen strains. This helps public health officials see connections that are useful in locating an outbreak source or to better understand the dynamics of human-pathogen interaction.

To illustrate, LAO has been heavily involved in helping move forward a WGS water project (led by FDA’s Center for Food Safety and Applied Nutrition through a cooperative agreement with the University of Maryland’s Joint Institute of Food Safety and Applied Nutrition) that includes Brazil, Argentina, Chile, and Mexico. The water project maps out the genome of pathogens in waterways to help better identify the source of pathogens and hopefully allow for mitigation to prevent outbreaks.

The OGPS’s Europe Office (EO) is also exploring collaborations with the European Food Safety Authority (EFSA) that may further expand the reach of the GenomeTrackr network. Together, EO and EFSA have established a technical ‘cluster’ working group to discuss issues related to the use of WGS in food traceability and outbreak investigations, such as interoperability, data sharing, bioinformatics tools, harmonization across methodologies, and novel sequencing technologies.

Smarter Tools and Approaches for Prevention and Outbreak Response

As new data streams and tools for rapidly analyzing data become available, we want to better explore their preventive value. By employing machine learning (ML) and artificial intelligence (AI), we can screen datasets in search of information on potential food outbreaks. Last year we launched a new pilot leveraging these smarter tools to screen imported seafood at ports of entry. Early indications are that AI/ML could almost triple the likelihood that we will identify a shipment containing products of public health concern.

Big data analytics could also be employed to modernize recall notification processes and develop enhanced early warning mechanisms on reported foodborne illnesses and pathogens isolated from food samples, information that potentially could be exchanged with and among other countries, subject to disclosure laws.

The blueprint also calls for exploring new approaches to inspection and oversight. FDA has conducted remote inspections of certain importers under the Foreign Supplier Verification Program’s rule during the COVID-19 pandemic. Similarly, the blueprint considers proof-of-concept activities to evaluate the feasibility of using remote, virtual, and/or component inspections of foreign and domestic firms with a demonstrated history of compliance, for agency prioritization purposes. We also will explore the use of reliable third-party audits to help prioritize inspections.


strengthening culture through field tech

FDA’s Office of Global Policy and Strategy has funded a cooperative agreement with the Inter-American Institute for Cooperation on Agriculture that explores how technology can be used to expand educational outreach of produce safety concepts, and thus support promotion of a food safety culture — by putting it directly in the hands of the growers.

Currently, most outreach is performed in person. The 5-year cooperative agreement, initiated in October of 2019, will evaluate the effectiveness of remote training delivered through newer technologies to understand their utility in promoting a food safety culture. This may include smart phone apps and other portable tech-based applications that can more readily and more quickly reach users than arranging for in-person training.


New Business Models and Retail Modernization

The blueprint prompts us to ask ourselves: What approaches can we as regulators take to help ensure food safety within a global food system that embraces both new business models that advance innovations in novel ingredients, new foods and new food production, and distribution systems, as well as traditionally-produced foods? How do we educate manufacturers, distributors, and retailers on the importance of basic food safety concerns in a marketplace that encompasses such a broad spectrum of practices? It is a challenge that is best served by talking to our partners and stakeholders, both domestic and international. For example, the growing digital world of e-commerce, encompassing a broad range of food businesses and shifting global supply chains, may pose unique challenges that can benefit from collaborations within the global regulatory community.

Food Safety Culture

As regulators, we embrace our role in promoting the development of a global food safety culture. We should foster, support, and strengthen food safety culture on farms, in food facilities, and homes — embracing the opportunities to do so, yet giving credence to the challenges and barriers that exist, and being mindful of differences in norms from country to country.

Food safety culture looks at ways we can encourage, shape, and incentivize behavior to meet our food safety and public health goals. We welcome creative dialogue with U.S. and global food stakeholders on food safety priorities and how to effectively communicate with producers and consumers.

This means recognizing behavioral science principles and striving to do more to influence and change human behavior, addressing how food industry employees and general consumers think about food safety and how they demonstrate a commitment to this goal. Unless we do more to influence the beliefs, attitudes, and, most importantly, the behaviors of people and the actions of organizations, we will not make dramatic improvements in reducing the burden of foodborne disease.

Going Forward

The blueprint is grounded in reality. It doesn’t address things that can’t be done. Instead, it talks about doing our work differently. But to be clear, the blueprint is not a law or regulation like FSMA. Instead, it’s an outline for a new way of moving forward to further enhance food safety. Just as we have been fruitfully partnering with both domestic and international stakeholders to implement the many elements of FSMA, we hope to collaborate with them as we roll out the vision of our New Era blueprint. Our intent, whenever possible, is to explore flexible approaches that are inclusive of and viable for food operations of all sizes.

Over the next decade, we believe that food commerce will evolve into a secure, connected, and interoperable digital forum, leveraging technology to cater to changing consumer behaviors and rising e-commerce. Such a modernized food safety system will allow for real-time access to data generated from all parts of the food supply chain (including food safety authorities, industry, and consumers), and support early identification of emerging hazards and effective risk assessment and management decisions.

Partnerships among regulatory authorities — in the areas of data standardization, data analytics, and open data — will be important factors toward an integrated global supply chain consisting of data-driven, digital, and traceable food systems. As other countries and regions, such as the European Union, also contemplate data strategies for food safety, FDA will look for collaborations to enable technology solutions of mutual benefit.

Working together with our global counterparts and food safety stakeholders, and thinking outside the box, we’ll create a more digital, traceable, and safer food system that advances food safety, improves the quality of food for consumers in the United States and all over the world, and better prepares us for unexpected events that could impact the food supply.



Ritu Nalubola, Ph.D., is director of the Europe Office.

Letitia Robinson, Ph.D., is director of the India Office.

Katie Serrano is director of the Latin America Office.

Vanessa Shaw-Dore, M.P.H., is director of the China Office.


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