- Speech by
Deputy Commissioner for Food Policy and Response - Food and Drug Administration
Video provided by the International Association for Food Protection of Deputy FDA Commissioner Frank Yiannas and Dr. Mindy Brashears of the U.S. Department of Agriculture giving the U.S. Regulatory Update at the association’s 2019 annual meeting.
(Remarks prepared for delivery)
A New Era of Smarter Food Safety
Good afternoon. I’m honored to be here today in the company of so many respected colleagues and friends from industry, academia and government who are all committed to doing whatever must be done to protect consumers from contaminated food and give them the confidence they deserve in the safety of the global food supply.
I am also honored to be sharing this stage with Dr. Mindy Brashears because the U.S. Department of Agriculture is such an incredible partner in the food safety mission we share. Whether it’s writing regulations or responding to outbreaks or responding to new technologies, we work together. The American people deserve that in their government.
As many of my colleagues at IAFP know, while I am fairly new to FDA, I’m not new to food safety. In fact, food safety has been my life’s work. While I arrived at FDA in December right before the government shutdown, I have spent the past 30 years working on food safety for two giants in their respective industries: the Disney Company and Walmart. At Disney, where I worked for 19 years, I was the Director of Safety and Health. At Walmart, which I joined in 2008, I was the Vice President for Food Safety. Millions of people visit Disney parks and resorts every year; hundreds of millions shop at Walmart.
Those are impressive numbers until you consider the number of people affected by the work we do at FDA and USDA, and by the work you do in your agencies, companies, universities and countries. What we do together - as food safety professionals - affects the health and well-being of families all over the world, from the largest cities to the smallest villages. It’s humbling; it’s challenging; and it’s exciting because at FDA we are standing on the threshold of a sea change in how we protect the food supply. It’s something that we are calling “A New Era of Smarter Food Safety.”
A Modern Approach for Modern Times
In my new role as Deputy Commissioner for Food Policy and Response, I am focusing on high-priority food safety issues and policies that cross boundaries within FDA. These include implementation of the FDA Food Safety Modernization Act (FSMA), coordination of food-related outbreak response, and evaluation of new and emerging technologies.
The latter is particularly timely because we are in the midst of a new revolution in food technology. Many believe there will be more changes in food production systems in the next 10 years than there have been in the past 50. Products will be reformulated; new food sources and production approaches will be realized, and the food system will become increasingly digitalized. As an agency – and as food safety professionals - we must adapt to the changing world around us to protect public health and facilitate innovation.
To succeed in these modern times, we need a modern approach. A lot has changed since FSMA became law in January of 2011. That’s why Acting Commissioner Ned Sharpless and I issued a statement in May announcing steps we plan to take to usher the FDA and the United States into a New Era of Smarter Food Safety. We plan to publish a blueprint that will outline how we’ll be leveraging technology, and other tools, to create a more digital, traceable and safer food system.
Smarter food safety isn’t just a slogan or a tagline. It’s much more than that. Instead, it’s a new approach to food safety, a new mindset, one that recognizes and builds on the progress made in the past but incorporates the use of new technologies that are being used in society and business sectors all around us, such as blockchain, sensor technology, the Internet of Things, and Artificial Intelligence.
But Smarter Food Safety is about more than just technology. It’s also about simpler, more effective, and modern approaches and processes. It’s about leadership and creativity.
Smarter Food Safety is people-led, FSMA-based, and technology-enabled.
We are actively working on developing the strategic blueprint by tapping expertise both within and outside the boundaries of FDA. Before I tell you about the areas we’re focusing on, I’d like to bring you up to date on a few issues we’ve been working on since I’ve joined the agency, beginning with produce safety.
Helping to Ensure the Safety of Leafy Greens
I arrived at FDA during the second of two outbreaks of E. coli O157:H7 last year that were tied to consumption of romaine lettuce. This outbreak, which made people sick in multiple U.S. states and Canadian provinces, essentially emptied all store shelves of romaine lettuce right before Thanksgiving while we were searching for the source of the contamination.
Our investigation highlighted the need for better management of agricultural water as well as the need for better traceability.
As you know, FDA is taking another look at the microbial water quality and testing standards in the Produce Safety Rule under FSMA to ensure that they are strong enough to protect public health but practical enough to be effective on farms of all size and type. We are committed to using the best science available to help minimize the risk that produce can become contaminated, including lessons learned from outbreak investigations. And we have been engaging with stakeholders through on-farm visits and other meetings to learn more about the diverse ways in which water is used. Compliance dates have been extended for the agricultural water provisions for all produce covered by the Produce Safety Rule other than sprouts. The new dates for compliance with water standards begin with large farms in January 2022.
I know that there are concerns about this delay in the compliance dates given the role that agricultural water has played in recent outbreaks. Let me assure you that working with the produce industry to make agricultural water as safe as it can possibly be is a priority for FDA and it is a priority for me personally. We are working with industry groups that include Western Growers and the Romaine Task Force to help minimize the risk of pathogen contamination.
Routine inspections of large farms, under the Produce Safety Rule, began this spring. States are conducting the majority of the domestic inspections under a cooperative agreement with FDA. FDA is inspecting farms in other countries that export produce to the United States.
We are engaged in collaborative research investigations with government and academic groups to sample agricultural water in the U.S. and internationally. These environmental water surveys are designed to increase our understanding of pathogen contamination and inform preventive measures that mitigate the risks. Water quality standards, inspections and testing – you see there’s a lot of good work underway.
Together, we must find a solution. No, together we WILL find a solution.
To address the need for greater traceability, FDA participated in discussions with industry that led to voluntary product labeling and dating to identify the origin of the romaine based on harvest region, along with information related to the date of harvest. This provides more targeted information to consumers.
We have strongly encouraged the leafy greens industry to adopt best practices for real-time, farm-to-fork traceability and state of-the-art technology to assure quick and easy access to key data elements when leafy greens are involved in a potential recall or outbreak.
Just think about this. At a time when most Americans across the country were sitting down with family and friends to celebrate over food – the nation was experiencing a nationwide food safety issue. The damage that does to consumer trust is hard to measure. Food safety to me is first about protecting public health, but it’s also about trust.
That’s why we want to tap into new technologies and data streams to identify outbreaks and trace the origin of a contaminated food to its source in minutes, or even seconds, instead of days or weeks.
Preventing Illnesses from Cyclospora
We’ve been working with the Centers for Disease Control and Prevention on another threat to public health associated with produce – illnesses caused by Cyclospora cayetanensis. This microscopic parasite can contaminate fresh produce or water and cause an intestinal illness called cyclosporiasis.
The number of reported cases has been rising in recent years and there were two significant outbreaks in 2018, one tied to salads sold in a quick-service restaurant chain that made more than 500 people sick in 15 states and another associated with prepackaged vegetable trays that made 250 people ill in four states.
FDA and CDC are working together to identify data gaps and research needs so that improved tools can be developed to detect, prevent and control Cyclospora contamination of food.
We are working to educate the grower community regarding best practices that can be used to avoid Cyclospora contamination. On farms, unhygienic practices can contaminate water and equipment, and farmers are looking for mitigation strategies. Last fall, the FDA created a webpage with information for farmers and a fact sheet on cyclosporiasis and fresh produce.
We are making great progress in implementing FSMA. The next important compliance dates begin this summer for the Intentional Adulteration Rule, which establishes requirements to prevent or greatly minimize acts intended to cause wide-scale public harm. The first IA compliance date is in a few days, July 26, for large businesses. Routine inspections to verify compliance with this rule will begin in March 2020 to give stakeholders more time to become familiar with resource materials, tools and training.
This rule has been controversial with some in the food industry, with concerns including the flexibility, cost and paperwork involved in meeting these new requirements. We have heard the concerns and have made significant progress in addressing them through draft guidance and a training curriculum. Our goal is to make implementation as practical and flexible as possible, while also protecting public health.
Another issue that has been important to stakeholders is the need to provide parity of oversight between domestic and foreign food producers. On February 25, we released the FDA “Strategy for the Safety of Imported Foods,” which describes how FDA is integrating our new import oversight tools with existing tools as part of a comprehensive approach to imported food safety.
The Foreign Supplier Verification Program under FSMA is a powerful tool in our import toolkit as we inspect U.S. importers to establish that they are meeting their responsibility to ensure the food they bring in meets FDA safety standards.
We began inspecting importers of processed foods under FSVP in June 2017, conducting about 1,600 inspections to date. We intend to begin routine FSVP inspections of produce importers this fall. (Both domestic and foreign inspections of farms covered by the Produce Safety Rule began in April.)
Now, let me turn back and close on what I’m most excited about, a New Era of Smarter Food Safety.
Smarter Food Safety – Initial Focus Areas
A lot of what I’ve already talked about involves work that I would consider Smarter Food Safety. In our response to outbreaks associated with fresh produce we’re talking about root cause analyses, data sharing and influencing behaviors. But to help crystalize this concept, let me tell you about what we’re talking about internally.
While on balance, I believe today’s food system is impressive when you think about the wide variety of foods available to many consumers for a fraction of their hard-earned dollars, I do believe today’s food system has one major Achilles heel: a lack of traceability and transparency.
There’s no question in my mind that there is a strong public health and business case for better traceability. I was involved in a blockchain pilot that traced mangoes back to their source, so let me use them as an iconic example here. I bought a package of mangoes at a local Walmart 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 farms in Mexico to two stores in North America. 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.”
In FSMA, Congress anticipated a need for enhanced tracking and tracing of certain food. Part of FDA’s work in modernizing food traceability will come through rulemaking under development that is required in Section 204 of the law. In the meantime, FDA is already exploring what this and other new technologies might mean to the agency with the announcement of new pilots with pharmaceutical products. The next logical step for us is to explore advances that can facilitate food traceability both for industry and regulators.
Smarter Tools and Approaches for Prevention
These days, we have more food safety data available to us than ever before, whether it’s data generated by the FSMA rules, increased data sharing with regulatory counterparts, or other sources. As more data streams and tools for rapidly analyzing data become available, another focus in developing the New Era blueprint is exploring their preventive value. How can predictive analytics help us target potentially contaminated foods?
For example, Americans expect their food to be safe whether it’s domestic or imported. And import food lines into the U.S. are growing year after year. The overall percentage of imported food consumed by Americans is about 15 percent, but it’s much higher for certain commodities, such as seafood and fruits and vegetables. To help us address this trend in a Smarter Food Safety manner, we have announced that we plan to conduct a pilot that will leverage artificial intelligence and machine learning to explore new ways to enhance the agency’s review of imported foods at ports of entry to ensure they meet U.S. food safety standards. Of course, we’ll also be using other tools, such as inspections of foreign farms and food facilities.
And the ability to apply predictive analytics to shape preventive measures will be particularly important as food innovation produces novel foods and food ingredients, such as cultured animal cells or macro- and micro-ingredients through innovative plant and microbial-based technologies, including those derived from genome-editing technologies. And data analytics can be equally important to support ongoing post-market review of food ingredients for safety. We want consumers to have the confidence in the safety of new and existing products that a transparent, data-driven food safety system can provide.
And we want to maintain U.S. global competitiveness by modernizing how we regulate novel technologies and products, creating predictable pathways for commercialization informed by shared data.
New Business Models and Retail Modernization
Another area we plan to address in our Blueprint is how we protect foods as new business models emerge and change to meet the needs of the modern consumer. The evolution of how food gets from farm to home continues from around the corner to around the world with the growth of international trade and the emergence of e-commerce and new delivery models. As food safety professionals, we must consider and try to keep pace with food safety challenges presented by new and emerging food business models.
For example, research indicates that as many as 70 percent of consumers in the U.S. will be grocery shopping online by 2025 – if not a few years sooner. That would give online shopping a 20 percent share of consumer food and beverage spending, or about five times the current level. This means new methods of delivery, packaging materials, temperature control approaches, and digital means of communicating with consumers are needed. We will work to identify the best food safety standards of care for these new and emerging food models.
Looking at more traditional business models, we’re exploring the best ways to ensure the safety of foods sold at restaurants and other retail establishments, which have been shown to be the most common nexus of foodborne illness outbreaks. CDC reported in February that of almost 4,700 outbreaks reported from 2009 to 2015 in which there was a single location of food preparation, restaurants were the most common location, followed by catering and banquet facilities.
And FDA baseline studies suggest that out-of-compliance rates for the retail risk factors have not changed much decade after decade. That’s why we’re committed to taking a fresh look at retail food safety and exploring new approaches that go beyond traditional training and inspections. For example, sick or infectious employees have been identified as a contributing factor in many cases. We must develop new approaches to changing behaviors at the foundation of food safety hazards in retail establishments.
Food Safety Culture
That’s a good segue to the fourth area of focus, Food Safety Culture, because I’m convinced food safety culture is a prerequisite to effective food safety management. You see, what we say about food or what we write about food safety matters, but it’s not what matters most. It’s what we DO that matters most – behaviors. That’s why the agency will be taking a fresh look at its role in promoting and recognizing the role of food safety culture in terms of food safety compliance. We’ll also be exploring how we approach our work in a way the leverages sound behavioral science principles to further enhance the likelihood of success.
Bottom line, we’ll do all we can to foster, support, and strengthen food safety cultures on farms and in food facilities. We will not make dramatic improvements in reducing the burden of foodborne disease without strengthening a culture of food safety and doing more to influence and change human behavior – what employees think about food safety and how they demonstrate a commitment to this goal in how they do their job.
Lastly, we know that a food safety culture must start on the farm but end in the home. That’s why we’re redoubling our efforts on consumer food safety education, which I know is also a priority for USDA, to spread the word and influence safe food handling behaviors in the home.
We know that we cannot embark upon this journey alone and, to be successful, it’s equally important for food companies of all sizes and technology firms, as well as local and federal agencies and other stakeholders, to join us in this effort. That’s why we plan to hold a public meeting this Fall to get additional input from external stakeholders on how our strategic blueprint should take shape. Please be on the lookout for the date and plan to join us. Your input will be invaluable. And after that, our plan is to produce a draft blueprint in January.
There’s power in beginning the New Era at the dawn of a new decade.
We’re in this Together
In closing, people have asked me why I decided to leave the private sector and join FDA. For me, the answer is simple. This is where I want to be.
I’ve learned from working with FDA from the other side of the fence that there’s a lot industry can do to advance food safety. And there’s a lot government can do to advance food safety. But what is crystal clear to me, having now been on both sides of that fence with some influential organizations, there’s so much more we can do together.
Whether you’re in the private or public sector, whether you’re at the state or Federal level, we’re all working for the same boss – consumers – so let’s work together to keep their food safe. They’re counting on us to do so.