The U.S. Food and Drug Administration has taken a landmark action that I believe will change the way government and industry work together to keep food safe and, in so doing, will help save lives for generations to come.
On Nov. 15, 2022, we released the final Food Traceability Rule and the list of human foods for which additional recordkeeping requirements will apply under the rule.
The benefits of improved food traceability cannot be overstated. In today’s interconnected and interdependent food system, much of the food we eat travels many miles. It passes through many nodes in the food supply chain, and, more often than not, what we know about the food and its journey from origin to consumer is limited. To help ensure the safety of food and its ingredients through all the steps in its journey, we must be able to follow its movement. That is the definition of traceability and the reason it is so vital for safeguarding public health and maintaining consumer confidence in the food supply.
The Rule
The Food Traceability Rule, which was mandated by the FDA Food Safety Modernization Act (FSMA), is also a cornerstone of FDA’s New Era of Smarter Food Safety that is building on what we’ve achieved through FSMA. The rule is designed to help the agency rapidly identify the source of contaminated foods on the Food Traceability List to prevent or mitigate the impact of foodborne illness outbreaks and address potential public health hazards.
It requires those manufacturing, processing, packing, or holding foods on the Food Traceability List to maintain key data elements (KDEs) – such as lot numbers and harvest locations – for critical tracking events (CTEs) along the food continuum and to send required KDEs to the next recipient of the food. Information can then be more easily connected so that a food can be tracked from farm to retail. This standardized, data-driven approach to traceability recordkeeping helps harmonize a universal language of food traceability that will help pave the way for industry to adopt and leverage more digital, interoperable, and tech-enabled traceability systems both in the near term and the future.
That common language will in turn help speed outbreak investigations and recalls, when needed. It will enhance our ability to conduct root cause analyses that will help us better understand how and where the food was contaminated in the first place and help prevent reoccurrences. And it will help minimize overly broad advisories or recalls that implicate unaffected food products.
While some believe that traceability is a reactive tool, I believe that better traceability is a game-changer for prevention, just like whole genome sequencing (WGS) has been. While WGS helps us detect foodborne illnesses by allowing us to link cases that may have previously been thought to be unrelated, we all know it has played a critical role in informing prevention. Better traceability will do the same. Think about it. With tools such as WGS, we’re increasingly identifying the pathogens and cases linked to foodborne illnesses, kind of like finding needles in the haystack. But even with this advanced technology, we can’t always find the haystack (the food and source) itself. That’s where traceability comes in.
Why it’s so important
This regulation will help fill critical gaps in a traceability system that has been largely paper-based and lacking standardization. Previously, we took one step forward to identify where the food has gone and one step back to identify the previous source, without a harmonized approach to the data elements needed to do this effectively.
During an outbreak of foodborne illness, this inability to rapidly track and trace a food can cost lives, millions of dollars in avoidable product loss, and damage to consumer trust. It also leads to food producers being unfairly impacted by contamination events that have nothing to do with their products.
Think about the Fall of 2018, when an outbreak of E. coli O157:H7 infections led to all romaine lettuce being pulled out of stores across the country right before Thanksgiving, because we had not yet identified the source of the contamination. The damage to consumer trust is hard to measure. Food safety is first about protecting public health, but it’s also about trust. We CAN and MUST do better.
We recognize that there will be many solutions available. While FDA will remain technology agnostic, through our New Era of Smarter Food Safety we will be very focused on issues like interoperability, governance, and common terminology on data elements to further improve food traceability.
And I can think of no better example of how using a standardized, data-driven approach to recordkeeping can work than by sharing a food traceability blockchain pilot I was involved with before I joined the FDA that traced sliced, packaged mangoes back to their source.
I bought a package of mangoes at a local store and asked my team to find out which farm they came from. Working with each stakeholder in the supply chain, they identified the farm in a mere six days, 18 hours, and 26 minutes. And that was pretty good when the average traceback can take weeks or even months.
Fast forward to the pilot using blockchain technology to trace mangoes from a retail outlet in North America back to its source or origin. For this test, each stakeholder in the supply chain, including farms, packing houses, transportation companies, importers/exporters, processing facilities, distribution centers, and stores, put data on the blockchain.
The blockchain linked these blocks of data together to show the journey this mango took from farm to store. The result was a steep reduction in the time it took to trace mangoes—from 7 days to 2.2 seconds! That is what I have referred to as “food traceability @ the speed of thought.”
The global impact
One of the keys to our efforts to enhance traceability will be its ability to scale – to be widely adopted by food operations of all sizes. While the Food Traceability Rule does not require electronic recordkeeping or the use of any specific technology, we do believe many in the food industry will voluntarily leverage digital tools to facilitate compliance.
To help ensure that traceability tools are affordable for small and mid-size companies, the FDA launched the New Era of Smarter Food Safety Low- or No-Cost Food Traceability Challenge in June of 2021. Ninety teams of entrepreneurs and thought leaders from all over the world participated and FDA chose 12 winners representing the U.S., Canada, and New Zealand. The winning solutions used a variety of approaches, platforms and technical designs that promoted private sector-led traceability innovation.
While FDA does not endorse or recommend the solutions that participated in the Challenge, they represent a snapshot of tools that could be considered when developing traceability systems. Beyond this initial Challenge, there are opportunities in the private sector to harness even greater traceability innovation. FDA is committed to continuing outreach with stakeholders to share information and learn new approaches within the tech-enabled traceability space.
This new regulation will have a ripple effect across the global food system in other ways. As food is a global asset, the foods on the Food Traceability List will be required to comply with the recordkeeping requirements in order to be sold in the United States, whether sourced in the U.S. or abroad. I believe that other nations will follow FDA’s lead and develop their own harmonized traceability requirements and infrastructures. In today’s global food system, borders between nations are blurred in the face of our shared commitment to food safety for consumers worldwide.
Stronger together
I believe that FDA’s Food Traceability Rule was written for the 21st century. I am very proud of the work that FDA has done to develop and finalize this rule, and appreciate the public comments that we received, which helped us to make it better.
This is just the beginning, and we all need to work together. There will be a continuing need for state and federal partnerships, as well as collaborations with the food industry. One of the mantras we’ve echoed throughout the FSMA process is that we will educate before and while we regulate. The need for this is clear and we will work with partners to assess industry educational needs while implementing the regulation and working toward the larger traceability goals articulated in the New Era of Smarter Food Safety. On December 7th we will hold a webinar to answer questions and hear concerns that can help inform future education, outreach, and communication efforts by FDA.
On December 7th we will hold a webinar to answer questions and hear concerns that can help inform future education, outreach, and communication efforts by FDA.
Webinar on the Food Traceability Final Rule – 12/07/2022 | FDA
The goal we share is end-to-end food traceability and greater food system transparency. And whether you’re in the private or public sector, we’re all working for the boss – the consumer – so let’s work together to keep their food safe. They’re counting on us.
About the author: Frank Yiannas is the Deputy Commissioner for Food Policy and Response at the U.S. Food and Drug Administration, a position he assumed in December of 2018. He is the principal advisor to the FDA Commissioner in the development and execution of policies related to food safety.
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]]>Despite the unprecedented challenges we’ve all faced during the COVID-19 pandemic, 2021 was another important year for the U.S. Food and Drug Administration’s Foods Program.
I’d like to highlight some of the strides we made last year in protecting the safety of human foods, which we will continue building on this year. They reflect on the work done by the dedicated teams in the FDA’s Office of Food Policy and Response, the Center for Food Safety and Applied Nutrition, and the Office of Regulatory Affairs.
FDA Food Safety Modernization Act (FSMA)
January 2021 marked the 10-year anniversary of FSMAbeing signed into law. Congress’ mandate then is still true today: It’s not enough to respond to outbreaks of foodborne illness, we must prevent them from happening in the first place. We continue to answer that call.
Most significantly, in December we published a much-anticipated proposed rule to establish revised standards for agricultural water to further strengthen the safety of produce. It would require certain farms to conduct annual assessments and, if necessary, implement measures to minimize potential risks. I believe this could be a game-changer for food safety because agricultural water has often been a factor in produce-related outbreaks.
Also in December, the FDA issued a final laboratory accreditation rule to improve the accuracy and reliability of certain food testing.
New Era of Smarter Food Safety
In our work to build on FSMA and our continued commitment to modernization under the New Era of Smarter Food Safety, I believe that we stand on the verge of a food safety revolution with new tools, technologies, and approaches to some of our most significant challenges.
One of those challenges is strengthening our response to foodborne illness outbreaks to inform future preventive activities. In December, the FDA released its Foodborne Outbreak Response Improvement Plan designed to improve the speed, effectiveness, and coordination of outbreak investigations. The priorities include tech-enabled traceability, root cause analysis, and outbreak data.
As an example of our focus on prevention, the FDA stressed the importance of examining and addressing recurring factors associated with outbreaks in a report on the investigation into the Fall 2020 outbreak of E. coli O157:H7 illnesses linked to leafy greens grown in California. In that report, released in April, the FDA expressed concern about a persistent E. coli strain O157:H7, which appears to be a “reasonably foreseeable hazard,” and found that the likely source of the outbreak strain was livestock, including those on adjacent lands.
Thinking Outside the Box to Strengthen Prevention
To further strengthen prevention, we know that we must think and act differently throughout the agency’s Foods Program.
The agency continues working towards finalizing the Proposed Food Traceability Rule to enhance the ability to trace food to its source. Our goal is to help ensure that traceability tools are affordable for small and mid-size operations. In June, the FDA launched the Low- or No-Cost Tech-Enabled Traceability Challenge to encourage the development of traceability systems that use low- to no- cost economic models. We received a record number of submissions, 90 from around the world, and chose 12 winning teams representing the U.S., Canada, and New Zealand. The winning submissionsExternal Link Disclaimer are smart, impactful, and cover the entire food continuum. We are actively working to communicate these ideas to the stakeholders that need them most.
The pandemic accelerated the need for alternative approaches when the FDA is unable to conduct traditional surveillance. Therefore, we have been conducting remote regulatory assessments at a variety of establishments, including remote inspections of importerssubject to the Foreign Supplier Verification Programs requirements under FSMA. We’re examining importers’ records to help ensure that foreign food suppliers are meeting U.S. safety standards. These remote assessments have provided valuable information to assist with regulatory decisions and resource targeting and we are now exploring what role they might play in our regulatory oversight toolbox.
We have been engaging our state partners and stakeholders in different ways. In 2021, the FDA signed domestic mutual reliance agreements with California, Florida, Utah, and Wisconsin. These agreements facilitate a coordinated effort to reduce human foodborne illness outbreaks, reduce duplication of regulatory oversight and focus on areas of higher risk.
And in 2021, we also marked the continued success of the FDA-funded Rapid Response Teams (RRTs) that respond to human and animal food emergencies in 24 states. The FDA released a videoExternal Link Disclaimer in 2021 showcasing the program.
Safety of Foods Ordered Online and a Culture of Food Safety
In October, we held a three-day summit to explore potential safety vulnerabilities in foods ordered online and delivered directly to consumers. The pandemic accelerated the need for a conversation about e-commerce as consumers increasingly order foods online in lieu of going to a store or restaurant. More than 4,100 people registered for the summit from over 44 countries, and almost 14,000 people have viewed the recordings. We are considering the input we received to decide on next steps.
Another New Era priority is supporting the establishment of a food safety culture on farms and in food facilities so that food safety is done the right way every day – not just because it’s the law, but because it’s the right thing to do. In November, the FDA began co-sponsoring a series of webinars with the non-profit Stop Foodborne Illness to engage experts in an exchange of ideas and experiences related to the importance of a robust food safety culture in helping ensure safe food production.
Reflecting on 2021 and Moving Forward in 2022
There is so much more that the Foods Program accomplished in 2021. For more on our work on food safety and nutrition, including efforts to reduce sodium intake and protect young children from toxic elements, I encourage you to read Acting Commissioner Janet Woodcock’s FDA 2021 Year in Review – Highlights Report.
In 2022, we will move forward on these achievements and others, including holding public meetings on the proposed revised agricultural water standards and releasing a final Food Traceability Rule. We are exploring the best uses of artificial intelligence and considering the most effective ways to unleash the power of data, which is so critical to advancing food safety.
I believe that, working together, we WILL bend the curve of foodborne illnesses in this decade so that consumers in this country, and around the world, can lead better lives.
About the author: Frank Yiannas is FDA Deputy Commissioner for Food Policy and Response
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]]>Editor’s note: Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response
Foodborne outbreaks can affect all of us, and the U.S. Food and Drug Administration is at the forefront of helping to protect consumers from foodborne illnesses. Every day, the agency takes steps to help protect the nation’s food supply. Our ability to do so successfully relies on continuously improving our surveillance system and providing timely and transparent updates to consumers about outbreaks when they occur.
To achieve these goals, we recently released a Foodborne Outbreak Response Improvement Plan, an important step to enhance the speed, effectiveness, coordination, and communication of foodborne outbreak investigations conducted by the agency. The Improvement Plan builds on years of work by the FDA to protect consumers from outbreaks of foodborne illness, working in close collaboration with state, federal and international partners in the public and private sectors.
There’s a lot at stake here. Each year, about 48 million people in the U.S. (1 in 6) get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases, according to the Centers for Disease Control and Prevention. But trust me, statistics don’t tell the whole story. We realize that behind every number is a real person with a real story of the painful consequences of foodborne illness.
That’s why FDA is laser-focused on prevention. We recognize that to advance food safety, we must be faster, more streamlined and more effective at identifying and locating food associated with illnesses and identifying root-cause factors to help prevent similar outbreaks in the future. We also recognize that sometimes advancing food safety means removing contaminated food from the market.
Public health advancements, such as whole genome sequencing (WGS), have improved our ability to detect foodborne outbreaks and allowed us to recognize that some of the outbreaks identified today may have previously gone undetected in the past. WGS has also allowed the agency to detect some outbreaks sooner compared to previously used laboratory methods and allows us to detect new and novel food vehicles of foodborne disease. These advancements are a good thing for public health. That said, in a large, distributed, and global food system, outbreak investigations remain challenging. As our ability to detect outbreaks improves, we must also strive to make improvements to our investigative processes, to ensure that we are able to quickly and effectively investigate outbreaks, prevent additional illnesses, understand the factors that allowed them to occur, and help prevent them from happening again.
Since the FDA Food Safety Modernization Act (FSMA) was signed into law in 2011, we have made great strides in modernizing and further safeguarding the U.S. food supply. This includes the recent release of a proposed rule to enhance the safety of pre-harvest agricultural water for produce (other than sprouts) covered by the Produce Safety Rule. Contamination of water used in farming operations has been a factor in certain outbreaks, and the proposed rule, if finalized, is designed to provide practical, effective ways to protect both water sources and public health.
In 2011, the FDA also created a permanent group, the Coordinated Outbreak Response and Evaluation (CORE) Network, dedicated to identifying, responding to, and assisting in the prevention of multi-state illness outbreaks linked to FDA-regulated food dietary supplements, and cosmetic products. In October 2020, as part of our further commitment to transparency, we began publishing the CORE Investigation Table, a weekly update that includes information on all foodborne outbreaks to which the FDA is responding and provides updates at each stage of an investigation. We aim to share information quickly and accurately during an outbreak investigation when significant details, such as the food that may be causing illnesses, may still be unknown.
The Improvement Plan released this month focuses on four priority areas in which improvements will have the most impact: 1) product traceback, 2) root-cause investigations, 3) outbreak data, and 4) operational improvements.
We collaborated with experts in both the public and private sectors during the development of this plan for input on how to strengthen the agency’s outbreak response. As part of this process, the agency contracted with the University of Minnesota’s School of Public Health to assess the FDA’s capacity to support, join, or lead multistate outbreak investigations as well as to provide recommendations for improvement, which were provided to the agency in a recently released report. The new Improvement Plan reflects our commitment to bend the curve of foodborne illness in the U.S., an overarching goal embodied in the FDA’s New Era of Smarter Food Safety.
In 2019, we announced the New Era of Smarter Food Safety initiative and in July 2020 published a blueprint outlining our goals over the next decade. The New Era initiatives build on what we have achieved in our implementation of FSMA by leveraging the use of new and emerging technologies, tools, and approaches. An example of work underway includes the proposed Food Traceability Rule. The proposed requirements in the rule would help the FDA rapidly and effectively identify recipients of certain foods to prevent or mitigate foodborne illness outbreaks. We believe this rule is a bridge to this New Era of a safer and more digital, traceable food system.
Conducting timely and effective foodborne outbreak investigations is a team effort that involves collaboration at the federal, state, and local levels. At the FDA, we understand we have an important role to play. We have a devoted team of public health professionals who work tirelessly, day and night, to accomplish this. But there are challenges in getting to the root cause of an outbreak given, among other things, the complexities of our food supply and the lack of transparency in the supply chain.
FDA is committed to strengthening food safety and we believe American consumers deserve to have confidence in the safety of the foods they eat themselves and serve their families. As we implement the goals outlined in the Foodborne Outbreak Response Improvement Plan, the New Era of Smarter Food Safety, and as we continue to implement FSMA, we will be transparent every step of the way. The American consumer deserves no less.
]]>When the U.S. Food and Drug Administration announced the New Era of Smarter Food Safety initiative in April 2019 and then released the blueprint in July 2020 outlining our goals, we put both in the context of doing our work differently, leveraging new and emerging technologies and approaches to create a safer and more digital, traceable food system.
We are taking two steps forward to do just that, working differently to enhance food traceability and support the use of technology to strengthen the food safety system.
On June 1, we will launch The FDA New Era of Smarter Food Safety Low or No-Cost Tech-enabled Traceability Challenge, asking stakeholders, including technology providers, entrepreneurs, and innovators, to develop traceability tools that can be implemented in a scalable, cost-effective way for food operations of all sizes.
And we recently launched a new quarterly podcast called TechTalk. The first installment, which posted on April 29, is about tech-enabled traceability. While the challenge is about new solutions, the podcast offers lessons learned, sharing experiences that food industry experts have had in developing industry-wide traceability initiatives to help keep food products safe.
The Traceability Challenge
Tech-enabled traceability – the ability to quickly track a food throughout the food system, from when it leaves its source to when it lands on your plate – is one of the foundational core elements of the New Era of Smarter Food Safety blueprint.
Achieving end-to-end food traceability will involve everyone in the supply chain – from source to table. To achieve that level of participation, we need accessible tracing solutions for human and animal food companies of all sizes. That means that we must help ensure that even small companies can use and benefit from new tracing technologies. Digitizing data at no or low cost through the use of creative financial models may allow the entire food system to get smarter together.
We’re asking food technology solution providers, public health advocates, entrepreneurs, and innovators across the human and animal food supply chain to present food traceability solutions that are affordable, create shared-value, and, thus, can scale to encourage widespread adoption.
When there’s an outbreak of foodborne illnesses, it’s critical to rapidly identify where the contamination originated. Doing so not only helps us prevent additional illnesses and potentially save lives, but it allows us to conduct better root cause analyses to prevent such outbreaks from happening again. It also may provide us with more detailed or specific information about the source of the contamination.
We also learned during the COVID-19 pandemic that further enabling a digitally traceable food system could help create the type of transparency needed to anticipate and help prevent supply chain disruptions in a public health emergency, thereby resulting in a more resilient food system.
The Low or No-Cost Tech-enabled Traceability Challenge is being overseen by the FDA’s Office of Food Policy and Response and administered by precisionFDA, which convenes community challenges and app-a-thons that galvanize dialogue and scientific discovery around technologies.
The challenge will invite submissions for tech-enabled solutions that address traceability needs and challenges faced by primary producers (such as entities involved in farming, fishing, and animal agriculture), importers, manufacturers and processers, distributors, and retailers and foodservice. There is a pre-registration web page that will be updated on June 1 at 8 a.m. ET with all the information needed to participate in the challenge until the submission window closes on July 30 at 5 p.m. ET. Up to 12 winners will be announced at the completion of the challenge.
While there is no cash prize, the challenge winners will gain significant visibility, including an opportunity to present their entry in a public forum hosted by the FDA. The food industry will gain new insights into how to solve traceability challenges, and the FDA will open the door to a conversation about finding new ways to overcome obstacles in the road to farm-to-fork traceability.
TechTalk Podcast
The TechTalk podcast is hosted by the FDA and focuses on cutting edge topics. Each quarter we will examine a different aspect of the New Era of Smarter Food Safety blueprint for which there are novel technological approaches and solutions. This podcast features top experts in the field involved in food safety and technology.
In the first installment in April, experts from the Institute of Food Technologists, FMI: The Food Industry Association, and the global standards organization GS1 discussed the role they envision new technologies playing in improving traceability, and the advice they have for food producers contemplating next steps in their traceability journey.
Future podcasts will explore the role of technology in the other New Era of Smarter Food Safety core element areas, including data and predictive analytics, e-commerce and retail food modernization, and food safety culture.
Doing our food safety work differently
Both the challenge and the podcast reflect how the FDA is approaching its food safety mission differently in the New Era of Smarter Food Safety, just as we have done in implementing the FDA Food Safety Modernization Act (FSMA). In developing and implementing the foundational FSMA rules, the FDA brought stakeholders to the table with an unprecedented level of outreach. With the New Era of Smarter Food Safety, the FDA is acting as a catalyst for change, seeking and distributing knowledge and bringing stakeholders together to find solutions.
We will always strive to keep consumers safe. But the process that leads to the kind of fundamental changes we’re talking about in the New Era of Smarter Food Safety blueprint is collaborative, recognizing that this is an evolution for the food industry. Thus, innovation that makes traceability more affordable may be the brainchild of innovators in the private sector. And lessons that can help companies envision using technologies to make their product safer may come from their counterparts in the food industry.
We invite you to learn more about the FDA New Era of Smarter Food Safety Low or No-Cost Tech-enabled Challenge, the TechTalk podcast, and the New Era of Smarter Food Safety initiative. Our ultimate goal is, and has always been, bending the curve of foodborne illness in this country by doing everything we can to prevent the contamination of foods.
One way to do that is to tap into the wealth of expertise and information that can be found in government, industry, academia and other resources in the public and private sectors. Working together, we will find the approaches we need to help ensure that modern advances in food and information technology are accompanied by modern advances in food safety.
About the author: Frank Yiannas is the deputy commissioner for food policy and response at the U.S. Food and Drug Administration, a position he assumed in December of 2018. He is the principal advisor to the FDA commissioner in the development and execution of policies related to food safety, including implementation of the landmark FDA Food Safety Modernization Act (FSMA). His responsibilities include food safety priorities such as outbreak response, traceback investigations, product recall activities, and supply chain innovation. Before joining the FDA, Yiannas was vice president of food safety at Walmart. Yiannas is a past president of the International Association for Food Protection (IAFP) and recipient of the 2007 NSF Lifetime Achievement Award for Leadership in Food Safety. He is also the recipient of the Collaboration Award by FDA in 2008 and he was named the 2015 Industry Professional Food Safety Hero Award by STOP Foodborne Illness, a consumer advocacy group.
Yiannas also is a past vice-chairman of the Global Food Safety Initiative. He is an adjunct professor in the Food Safety Program at Michigan State University. In 2017 he received the university’s Outstanding Faculty Award. A microbiologist, Yiannas received a bachelor’s degree in microbiology from the University of Central Florida and a Master of Public Health degree from the University of South Florida.
]]>Ten years ago, on Jan. 4, 2011, the FDA Food Safety Modernization Act (FSMA) was signed into law and Congress’ mandate was clear: It’s not enough to respond to outbreaks of foodborne illness. We must prevent them from happening in the first place. FSMA was fueled by widespread concern among lawmakers, public health agencies, industry and consumers after multi-state outbreaks of foodborne disease had caused severe illnesses and deaths in thousands of people and animals in the United States.
The result was the largest overhaul of the nation’s food safety system since the Federal Food, Drug and Cosmetics Act of 1938.
A decade later, what can we say has been accomplished?
Because of FSMA, those who grow, produce, pack, hold, import and transport our food are now taking concrete steps every day to reduce the risk of contamination. The result is safer food in this country, whether that food is produced domestically or imported.
Importantly, and as a result of FSMA, there has been a bigger conversation about the importance of food safety over the past decade. This call to action has emanated from the halls of Congress to farms, food production facilities, corporate boardrooms and consumers all over the world.
We recognize that there’s still work to be done. We began with a vision of where we were headed and a willingness to change course when necessary. Truthfully, there have been challenges we didn’t anticipate. Food production is constantly evolving, as are the pathogens that can cause contamination. We’ve worked with stakeholders to ensure that the requirements don’t just look good on paper but work well in practice.
We have tried our best to be up front about what we are doing and why. In fact, transparency is a hallmark of this journey we call FSMA.
Where we started
Once FSMA became law, the U.S. Food and Drug Administration set off on a collaborative path to transform our food safety system. FDA leaders and experts sought input from farmers, manufacturers, distributors and others along the global supply chain. This unprecedented level of outreach shaped the draft versions of the FSMA requirements after hundreds of site visits, public meetings and listening sessions.
Even as we began finalizing FSMA requirements five years ago, the need for change was evident. For example, we heard from stakeholders that certain standards for agricultural water – a factor in some outbreaks tied to produce – were too complex and difficult to implement. We pushed back the compliance dates, embarked on hundreds of farm tours, and will be proposing new agricultural water requirements that we believe are both feasible and effective.
With FSMA, we began doing our work differently by working more closely than ever with the food industry, with domestic and foreign regulatory counterparts, and with consumer advocacy groups. Together, we share the recognition that keeping food safe is good for public health, it’s good for business, and it’s simply the right thing to do.
FSMA progress
We have finalized the seven foundational rules outlining the risk-based preventive measures that are required of those covered by FSMA who grow, manufacture, process, pack, store and transport domestic and imported foods.
Facilities that produce human and animal food must have food safety plans that include an analysis of hazards and risk-based preventive controls to minimize or prevent these hazards. These rules include Current Good Manufacturing Practices requirements and preventive standards for animal food producers. Keeping foods safe for companion and food-producing animals is an important part of an effective food safety system.
FSMA dramatically changed regulatory oversight of produce and food importers. There are now science-based, regulatory standards under FSMA for growing, harvesting, packing and holding fruits and vegetables. Importers are responsible for verifying that their foreign suppliers are meeting the new FDA safety standards aimed at prevention and there is a program for the accreditation of third-party auditors to conduct food safety audits of foreign entities.
We have worked closely with regulatory counterparts in Canada, Mexico, Europe, China and other trading partners to strengthen safety oversight of food coming to the U.S.
Food transport companies must prevent practices during transportation that create food safety risks. Food defense is another priority, with certain registered human food facilities required to reduce their vulnerability to intentional adulteration intended to cause widespread public harm, including acts of terrorism.
We have additional enforcement authorities, such as mandatory recall when a manufacturer fails to voluntarily pull unsafe food from the market and suspension of registration to prevent a facility from selling or distributing unsafe food.
If finalized, the proposed Food Traceability Rule, published in September 2020, would establish the foundational components to harmonize the key data elements and critical tracking events needed for enhanced traceability. It would, in essence, allow the food safety system to speak the same traceability language, helping to more rapidly identify the origin of contaminated food.
Strengthening Partnerships
The agency has also leveraged our work with state leaders, industry, academia and public-private alliances to increase our impact. We have developed partnerships and worked steadily towards our vision of an integrated food safety system through collaborations such as domestic mutual reliance with state and local partners that are defined by sharing and harmonization.
The FDA has worked closely with our state partners on FSMA implementation, including providing training in the FSMA standards for both state and federal regulators so that there is consistency in approach no matter which agency is inspecting a covered farm or facility.
We have invested millions of dollars in cooperative agreement programs that support state efforts to oversee compliance with FSMA rules, specifically the preventive controls rules for human and animal food and the produce safety rule.
We have developed new information-technology platforms, published dozens of guidance documents and provided technical assistance.
Going forward – A new era of modernization
Modernization is not something you do just once. At the FDA, it’s one of our guiding principles and our commitment to the public we serve. We are building on our FSMA achievements through the New Era of Smarter Food Safety initiative announced in April 2019 to create a more digital, traceable and safer food system. The New Era of Smarter Food Safety blueprint, released in July 2020, creates a 10-year roadmap for reaching this goal.
The blueprint builds on the work that FDA has done under FSMA to encourage and incentivize industry to voluntarily adopt new technologies that can lead to the end-to-end traceability that could help protect consumers from contaminated food.
Similarly, the blueprint looks at new ways of helping to ensure that industry is meeting its responsibilities under the FSMA rules. For example, the FDA will look at the feasibility of using technology to conduct remote or virtual inspections and will encourage industry’s use of sensor technology to monitor critical and preventive control points.
New Era initiatives will also enhance the use of root cause analysis in cases where preventive control measures fail. Root cause analyses can advance our understanding of how a food is contaminated and help industry bolster preventive controls. The leaders who envisioned FSMA had just this kind of continuous improvement in mind when they created a flexible regulatory framework that can adjust with advancements in science and technology.
Another priority in the New Era blueprint is the continued establishment and development of food safety cultures on farms and in food facilities all over the world. While the importance of shaping attitudes and commitments to food safety has always been central to FSMA, the New Era will advance this principle to help ensure that every link in the global supply chain understands the importance of the steps they are taking under FSMA to protect consumers.
So have we advanced food safety, together, over the past 10 years? Definitely.
Have we accomplished everything we wanted to help ensure that the food you serve your family is safe? The honest answer is that we’re still working on that. We are working diligently to ensure that remaining FSMA rules and related guidance documents are finalized and implemented. But even when we have reached all of those milestones, we will always be working with industry on continuous improvement based on the latest science and the application of new technologies. Every day we will do our utmost to make our nation’s food as safe as it can be.
For 10 years, dedicated teams of FDA experts, as well as many stakeholders, have been working to implement FSMA. I don’t want to close without acknowledging their unwavering dedication to building a prevention-oriented food system that will help keep all of us safe from foodborne disease. There’s no doubt in my mind that their commitment has, and will, save lives.
With each year, the FSMA requirements become more embedded in the global food system and serve as the critical foundation to build on during our modernization journey into a New Era. In this manner, we’ll continue to work together, think outside-the-box, and create a more digital and traceable food system that further advances food safety and improves the quality of life for consumers in this country and all over the world.
About the author: Frank Yiannas is the deputy commissioner for food policy and response at the U.S. Food and Drug Administration, a position he assumed in December of 2018. He is the principal advisor to the FDA commissioner in the development and execution of policies related to food safety, including implementation of the landmark FDA Food Safety Modernization Act (FSMA). His responsibilities include food safety priorities such as outbreak response, traceback investigations, product recall activities, and supply chain innovation. Before joining the FDA, Yiannas was vice president of food safety at Walmart. Yiannas is a past president of the International Association for Food Protection (IAFP) and recipient of the 2007 NSF Lifetime Achievement Award for Leadership in Food Safety. He is also the recipient of the Collaboration Award by FDA in 2008 and he was named the 2015 Industry Professional Food Safety Hero Award by STOP Foodborne Illness, a consumer advocacy group. A microbiologist, Yiannas received a bachelor’s degree in microbiology from the University of Central Florida and a Master of Public Health degree from the University of South Florida.
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]]>A critical part of the U.S. Food and Drug Administration’s mission is safeguarding the human and animal food supply, helping to ensure that our food is not contaminated at any point during its journey along the supply chain.
COVID-19 is a new frontier for all of us as we deal with the realities of a pandemic and the impact it is having on our lives, on our families, our communities, and on our work. The FDA is committed to protecting the health of the American people, and to facing any challenges in food safety and access that arise during this public health emergency. That has never been more true than now.
So, let me assure you first that the U.S. food supply remains safe for both people and animals. There is no evidence of human or animal food or food packaging being associated with transmission of the coronavirus that causes COVID-19.
Unlike foodborne gastrointestinal viruses like norovirus and hepatitis A that make people ill through contaminated food, SARS-CoV-2, which causes COVID-19, is a virus that causes respiratory illness. This virus is thought to spread mainly from person to person. Foodborne exposure to this virus is not known to be a route of transmission.
For these reasons, we do not anticipate that food products would need to be recalled or withdrawn from the market for reasons related to the outbreak, even if a person who works in a human or animal food facility (e.g. a food packager) is confirmed to be positive for the COVID-19 virus.
No current disruptions in the supply chain
There are currently no nationwide shortages of food, despite localized reports of shortages. Speaking personally, I’ve had the same experience that many other consumers have had of going to my neighborhood grocery store and seeing shelves empty of certain items. But based on our ongoing communication with industry, we understand this is largely an issue of unprecedented demand – not a lack of capacity to produce, process and deliver – and manufacturers and retailers alike are working around the clock to replenish shelves.
Food production and manufacturing – for both people and animals – are dispersed throughout the U.S. and there are currently no widespread disruptions reported in the supply chain.
Overall, retail supply chains remain strong, and the FDA is working with food manufacturers and grocery stores to closely monitor the human food supply chain for any shortages. The agency is in close contact with industry and its trade associations, which are in touch with their members about supply chain issues.
The same is true for animal food. The FDA is monitoring the availability of foods for livestock and pets. There are no shortages, and no current disruptions in the pet and livestock food supply chain.
Protecting government and industry workers
We have an unwavering commitment to protecting the health of FDA, state, and local personnel on the front lines of food safety as well as the health of the workers on farms and in human and animal food facilities all over the nation who play critical roles in helping to feed Americans and our animals every day.
We’ve taken steps to help reduce the risk of infection for FDA investigators and state inspectors in ways that won’t interrupt the process of how safe foods reach the market. Specifically, we have postponed routine surveillance inspections of domestic human and animal food facilities and farms out of concern for the health and well-being of FDA investigators and state inspectors and to respect industry safety concerns about visitors. We will, however, continue to inspect “for cause” when a potential threat to public health (human or animal) is identified.
As FDA Commissioner Dr. Stephen Hahn announced last week, we have also postponed most foreign inspections through April 2020 because of restrictions on travel and concerns about the safety of our investigators. We have other tools and authorities to help ensure the safety of imported foods, including inspections at the ports of entry and the use of PREDICT, our risk-based import screening tool to focus our examinations and sample collections.
We have also issued guidance on the FDA’s intention to temporarily not enforce onsite audit requirements for supplier verification under the FDA Food Safety Modernization Act (FSMA). These audits are designed to confirm compliance with safety standards but travel restrictions will likely prevent receiving facilities and importers from obtaining them.
For verification that would include a domestic or foreign onsite audit, facilities are expected to temporarily select an alternative way to verify compliance with food safety standards, such as sampling and testing, or food safety records review.
Regulations require actions to control risks for workers in food facilities
We care about workers in human and animal food facilities – their risk of infection and problems they may have getting to and from work with curfews and quarantines in certain places. Some protections live in the FSMA requirements that human food facilities have food safety plans to control risks associated with workers who are ill, regardless of the type of virus or bacteria. There are also requirements for human food facilities to maintain clean and sanitized facilities and food contact surfaces. Food-service workers also must continue to practice frequent hand washing and glove changes before and after preparing food. The animal food regulations also include requirements for cleanliness of the facility and personal cleanliness of employees.
If an employee is confirmed to have COVID-19, employers should inform workers of their possible exposure while maintaining confidentiality. Employees exposed to a co-worker with confirmed COVID-19 should follow the Centers for Disease Control and Prevention’s guidance: What to do if you are sick with coronavirus disease 2019 (COVID-19). Employers should consult with their local health department for additional guidance.
If you have questions
The FDA’s website, www.fda.gov/coronavirus, has a wealth of information on the most recent developments in areas that include testing and therapeutics, plus links to related information provided by other government agencies.
We have posted a new set of frequently asked questions at fda.gov/food and will be updating often. Also, questions can be submitted directly to the FDA via www.fda.gov/FCIC (for human food) and [email protected] (for animal food) and we will respond as quickly as possible.
If food facilities are experiencing issues regarding the supply chain, delivery of goods, or business continuity, please contact the FEMA National Business Emergency Operations Center at [email protected]. This is a 24/7 operation and they can assist in directing inquiries to the proper contact.
The strength of partnerships
Addressing this crisis is a team effort and it involves an all-of-government approach and public-private collaboration. I am part of a White House-level Coordinating Committee on the supply chain, and I can assure you that this group has broad representation from all components of the federal government that need to be in close coordination in monitoring the supply of human and animal foods. We are working with the food industry, and our state, local, and international regulatory partners to monitor and mitigate any impact on food safety and food access for the American public.
The FDA is also working with our partners to address reported challenges associated with quarantines and travel restrictions that may be impeding food workers’ ability to continue to work and transport product. This includes working with local, state and federal officials, and industry, to help ensure that food workers can get to and from their jobs in communities where curfews and shelter-in-place directives are enforced.
This is especially important in light of a guidance issued by Department of Homeland Security on March 19 in which workers in the food and agriculture sector – including those working in agricultural production and food processing of both human and animal food, distribution, retail and food service, and allied industries – are named as essential critical infrastructure workers who are vital to community continuity and resilience.
Consumers can be confident in the safety of their food. We will continue our efforts to make sure that they have access to the foods they need for themselves, their families (including their pets), and the animals our farmers raise.
Food producers of all kinds and all sizes should know that the FDA stands shoulder to shoulder with them throughout this crisis to ensure that food is safe and available for all Americans. And that we all will get through this, together.
About the author: Frank Yiannas is the deputy commissioner for food policy and response at the U.S. Food and Drug Administration, a position he assumed in December of 2018. He is the principal advisor to the FDA commissioner in the development and execution of policies related to food safety, including implementation of the landmark FDA Food Safety Modernization Act (FSMA). His responsibilities include food safety priorities such as outbreak response, traceback investigations, product recall activities, and supply chain innovation. Before joining the FDA, Yiannas was vice president of food safety at Walmart. Yiannas is a past president of the International Association for Food Protection (IAFP) and recipient of the 2007 NSF Lifetime Achievement Award for Leadership in Food Safety. He is also the recipient of the Collaboration Award by FDA in 2008 and he was named the 2015 Industry Professional Food Safety Hero Award by STOP Foodborne Illness, a consumer advocacy group.
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]]>This first World Food Safety Day is a recognition that when it comes to food safety, we all win or lose together. In a global food system and with the increase in international travel, if foodborne disease exists somewhere in the world, it can exist anywhere in the world. No nation stands alone when faced with the challenge of protecting its citizens from foodborne illnesses. This truth is reflected in the theme of this inaugural event: “Food Safety Is Everyone’s Business.”
I am honored to be representing the U.S. Food and Drug Administration today. This is a wonderful opportunity to talk about the importance of food safety and how we can work together to improve quality of life for people in every nation. But first I would like to acknowledge and thank the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) for all that they do to advance food safety worldwide.
Food safety is an issue that transcends international borders. Foodborne pathogens do not recognize boundaries or borders, so when it comes to protecting consumers, neither should we. It’s estimated that foodborne illnesses are responsible for 420,000 deaths annually around the world, 125,000 of them in children under age 5. Think about that. It’s not just a sad statistic – it’s a public health call to action. It’s almost twice the estimated deaths in the earthquake that hit Haiti in 2010. It’s roughly 229 times the people who died when Hurricane Katrina hit our Gulf Coast in 2005. In the United States alone, the Centers for Disease Control and Prevention estimates that 3,000 people die each year from foodborne illnesses.
Taking a world view of food safety is important for all consumers because food moves globally, as do we. In the U.S., about 15 percent of the food supply is imported from more than 200 countries or territories, including 32 percent of the fresh vegetables, 55 percent of the fresh fruit and at least 94 percent of the seafood that Americans eat each year. And these statistics are not unique to the U.S. – similar patterns are seen around the world and global movement of foods continues to grow.
The FDA fully supports this united effort to advance the prevention, detection and mitigation of foodborne risks. But this is not something we can do just one day a year; our mission is one that must be carried out every day, anywhere where food is produced, 365 days a year.
To protect the food supply, we must use a variety of tools. Rules, response and compliance activities are common, and critical, tools for food policy makers and regulators. But as nations we must go beyond merely having rules and regulations. We must also foster, support, and strengthen food safety cultures on our farms, in our food facilities, and in our nations. We will not make dramatic improvements in reducing the global burden of foodborne disease without strengthening a culture of food safety and doing more to influence and change human behavior. In fact, I like to say, simply put, food safety equals behavior.
So, what is a food safety culture? It’s patterned ways of thought and behavior that characterize a social group, whether it be a farm, a company, a geographic region, or a nation. Those patterned ways of thought and behavior can be learned through socialization processes and persist through time.
You see, I believe food safety can be caught, not only taught. I also believe that a food safety culture is a prerequisite to an effective food safety management system.
How do we promote food safety culture as public health agencies and organizations? To me, it’s a matter of always thinking and speaking about food safety to food producers and each other about the idea that food safety transcends regulations and borders. It’s the idea that food safety is a belief that all consumers matter, that we care about their safety and the safety of their friends and families. It’s also about being guided by the “why” food safety matters. There are such compelling reasons that whenever we don’t address the “why,” it’s a lost opportunity.
Why are we doing this? Because consumers deserve to be confident in the safety of the food supply. Because farmers and food manufacturers want their customers, as well as their business, to thrive. But most importantly: Because too many of our citizens are still getting sick and dying of foodborne illness – and we can do better. No, we MUST do better.
As we look towards the future, there’s no question that we must all continue to work on creating a stronger, global culture of food safety, together.
At FDA, our work towards this goal is set in the framework of three missions set forth by Congress and FDA to prevent foodborne illnesses, create a modern food safety system, and empower consumers to make informed choices about their diet.
First, there is the FDA Food Safety Modernization Act (FSMA) that FDA has been implementing since it was signed into law in 2011. Under FSMA, science and risk-based standards have been put in place for the production, packing, holding and transportation of foods. Many of companies that produce our foods – no matter where in the world they are located — must systematically recognize what hazards may exist and routinely take steps to prevent them.
Second, Acting Commissioner Ned Sharpless and I recently announced an initiative called a New Era of Smarter Food Safety that will leverage new and emerging technologies to further our food safety goals. This is a new approach to food safety, one that explores the use of the technologies being used in society and business sectors all around us, such as blockchain, sensor technology, the Internet of Things, and Artificial Intelligence, to create a more digital, traceable, and safer food system. And one that creates shared value for all stakeholders — farmers, food producers, regulators, consumers, and the planet.
Third, there’s FDA’s Nutrition Innovation Strategy that FDA announced in 2018 to empower consumers with information and facilitate industry innovation to create healthier products, to help combat the growing burden of chronic disease. This strategy includes implementing the updated Nutrition Facts label and requiring that certain menus and vending machine labels include calorie information. These are just two of the ways in which FDA is helping consumers find the information they need to make healthful food choices.
In closing, I look forward to discussing how we can work together as the citizens of all nations, large and small, to ensure that everyone has access to safe, affordable, and healthful foods.
There’s a role for everyone in this important work. A World Food Safety Day page at fda.gov has valuable information about how to participate in spreading the word about food safety and what you can do to avoid foodborne illnesses.
No matter where we live or where we work, we’re all serving the same boss. The consumer. So, let’s get to work, because they’re counting on us and food safety is everyone’s business, 365 days a year.
About the author: Frank Yiannas has been the deputy commissioner for food policy and response at the U.S. Food and Drug Administration since December of 2018. He is the principal advisor to the FDA commissioner in the development and execution of policies related to food safety, including implementation of the Food Safety Modernization Act (FSMA). His responsibilities at FDA include outbreak response, traceback investigations, product recall activities, and supply chain innovation.
Before joining the FDA, Yiannas was vice president of food safety at Walmart. He worked for the retailer for 10 years. Yiannas is a past president of the International Association for Food Protection (IAFP) and recipient of the 2007 NSF Lifetime Achievement Award for Leadership in Food Safety. He received the Collaboration Award by FDA in 2008 and was earned the 2015 Industry Professional Food Safety Hero Award from STOP Foodborne Illness, a consumer advocacy group. Yiannas also is a past vice-chairman of the Global Food Safety Initiative (GFSI). He is an adjunct professor in the food safety program at Michigan State University. In 2017 he received the university’s Outstanding Faculty Award. A microbiologist, Yiannas received a bachelor’s degree in microbiology from the University of Central Florida and a Master of Public Health degree from the University of South Florida.
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]]>The food system has been changing since the dawn of time, but never more rapidly or dramatically as it has the potential to do so today. After countless millennia as hunter-gatherers and subsistence farmers and a century or so of industrial farming and modern retail, we are now entering a new era.
Today, whether we live in Shenzhen, Santiago, Sheffield or Chicago, we shop at modern retail stores with tens of thousands of products on the shelves. We fill our shopping baskets with fresh and frozen foods without regard for the season. We can choose to buy local or enjoy the best products from the best producers anywhere in the world. We go online and get whatever we want delivered direct to our door or local store.
This choice, affordability, and convenience is the result of many extensive developments throughout the food supply chain, but one development stands out to me as the most inspiring and impactful. It’s not a technology or a business model: not the Internet of Things or mobile commerce or globalization. Nor is it a new idea; it’s one our hungry cave-dwelling ancestors knew and understood. It’s called “collaboration.”
Food safety without borders
I’ve been in the food industry for more than 30 years and I work for the world’s largest retailer. With operations in 28 countries, selling fresh groceries and food items both in-store and online, we work with food producers, regulators, academic institutions, transportation companies, and others within and between countries the world over.
As food industry professionals, we know that hazards in the food supply don’t recognize borders or boundaries, so we can’t limit our food safety systems in this way either. As long as foodborne disease exists somewhere in the world, it can exist anywhere in the world. And when others win battles against foodborne disease, we all win.
Regulators in China, Europe, the United States and elsewhere are now collaborating to create better food safety laws and regulations, and private sector companies are increasingly sharing food safety best practices. But we need to do much more than this.
An idea born in China
Last year, we announced the Wal-Mart Food Safety Collaboration Center in China and called for partners in the food system to participate. Our aim is to help accelerate the development and adoption of food safety solutions that can be openly shared and scaled throughout the supply chain. We will bring together Chinese and international expertise to help identify food safety issues in China and to find practical solutions to these challenges. Wal-Mart and the Wal-Mart Foundation plan to invest $25 million over five years on projects to advance food safety in China.
The center will open its office March 29, when it will host the first meeting of its international board of experts and set its plans for the year. It has already received overwhelming support from government officials, industry associations, academia and businesses in China and the U.S.
For the center to succeed, these parties will need to work together. But to achieve the broader aim of safer food for everyone, something that is much more difficult needs to be achieved: industry-wide collaboration. This means nothing less than transparency and trust that scales across the farm-to-fork supply chain.
Building with blockchain
One of the first projects to come out of the Wal-Mart Food Safety Collaboration Center addresses this. It is a blockchain pilot being driven jointly by IBM, suppliers and Tsinghua University. Blockchain is the technology behind cyber-currencies like Bitcoin. It creates a digital, permanent ledger that links blocks of data together in an unbroken chain, allowing unrelated stakeholders to jointly keep a secure and reliable record of important data attributes and transactions. No one can change or remove the data, and it’s not centralized; everyone has access to it.
Our blockchain pilot test in China is starting with pork and tracing it from farm to table.
This technology could enable me, as the retailer, to be able to digitally track individual pork products in minutes, not days. I’ll know the farm, the factory, the batch number, storage temperature and shipping details. I’ll be able to tell if this product is authentic and safe, and when it expires. If a food contamination issue arises at the farm or factory, I’ll know which products to recall, and which may be left on the shelves.
21st Century transparency
China’s situation may seem unique. After all, it’s facing rapid economic growth and urbanization, as well as considerable changes to food consumption habits. It has traditional agricultural practices alongside modern farms, and traditional wet markets as well as modern supermarkets. Transportation and logistics are developing rapidly, with efficient urban infrastructure but underserved and remote rural districts.
Even so, it’s clear that today’s food system is more global and interconnected than ever. Markets as diverse as China, Chile, the UK and the U.S. are actually more alike than they seem at first glance.
When I sit down to enjoy one of my favorite desserts, tiramisu, I know that that I am looking at a multitude of ingredients, sourced from all over the world: cream from the U.S., chocolate from Belgium, vanilla from Madagascar, coffee beans from Colombia. My tiramisu may appear simple yet is made up of some of the world’s finest ingredients, and I care about the quality of every one.
Now imagine there’s a global recall of a certain brand of chocolate. As a consumer, I’d like to know that the chocolate in my tiramisu is not involved. As the food producer or retailer, I want this information too, and I need it immediately to minimize the impact on my business.
Blockchain technology has the potential to provide this level of traceability as part of a digitized food system. It can also take us beyond traceability to transparency, where we have a complete and interconnected view of the supply chain. We hope this will lead to new insights that can further improve supply chain efficiencies, promote sustainability, and reduce food waste.
Transparency will be a game changer in the world of food safety in the 21st Century. It’s technically possible today and, with China on the leading edge of this shift, it’s closer than you might think.
Note on author: Frank Yiannas is vice president of food Safety at Wal-Mart. Yiannas is the past president of the International Association for Food Protection (IAFP) and recipient of the 2007 NSF Lifetime Achievement Award for Leadership in Food Safety. Yiannas is the author of two books: “Food Safety=Behavior” published in 2015 and “Food Safety Culture” published 2008.
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