AFI Association of Food Industries


AFI Serving the U.S. Food Import Sector

2020: FDA Preparing for a New Era of Smarter Food Safety 

Norman E. “Ned” Sharpless, MD
Commissioner of Food and Drugs, FDA

This article contains excerpts from a speech given by FDA Commissioner of Food and Drugs Ned Sharpless at an October 2019 public meeting hosted by FDA.

I’m delighted to join you today for this important meeting to gather public input on our proposal for a “new era of smarter food safety.” As a doctor, I’ve long appreciated the importance of nutrition and diet and the role it plays in health and disease. Obesity is a leading cause of cancer in this US, and so I was very interested in the topic of nutrition, given that I am cancer doctor and had been working at National Cancer Institute. I also was well aware that research could be better in this area, having co-chaired a trans-NIH working group addressing research priorities in nutrition.

But food safety specifically – the issue of how to prevent food borne illness – was frankly not something I had thought much about since medical school, with topics like salmonella, Listeria, and E. Coli, being the subjects of medical board questions.

So, when I was preparing to come to FDA, this topic provided cause for some trepidation. But I have to say that I’ve found the topic of food safety fascinating and the FDA’s work in this area very rewarding. And through long conversations with Frank Yiannas and others, I have realized the topic is not as foreign as I thought.

Some of the epidemiologic approaches I knew well from studying cancer clusters are not dissimilar to approaches used in studying food outbreaks. And that experience taught me the power of, and the critical need for, great data and great data analysis. That research is very dependent on how we can collect high quality data and how we analyze those data using cutting-edge analytical tools. And I realized how excited I am about our opportunity to support the modernization of our system to help prevent and ensure more timely responses to foodborne illness outbreaks.

Food safety is a critical public health responsibility that this agency takes very seriously. We have oversight of approximately 80 percent of the foods Americans eat – including seafood, fresh fruits and vegetables, milk and dairy products, baby food and infant formula, frozen, canned, packaged and snack foods, juice, soft drinks and much more. In short, the FDA’s responsibility in this area touches every American, every day of our lives. 

So, one of the first things I did when I learned I was coming to FDA was to commit myself and FDA to advancing the vision of a “New Era of Smarter Food Safety”. This began as I was transitioning to the agency. I learned early on about the FDA’s plans that were being developed and immediately I appreciated what an important opportunity it offered to make an impact in this area. Last spring, right after arriving at the FDA, I was pleased to join with Frank to announce the steps we planned to take to usher the FDA and the United States into a “New Era of Smarter Food Safety”. 

As you are aware, our proposal is a dynamic initiative with enormous potential to make a difference in the lives of all Americans. As I mentioned, several of the issues this initiative focuses on – including strengthening predictive capabilities, accelerating prevention, speeding response and using and analyzing data – are things I really understand from my time as NCI director, working on cancer treatment and prevention.

I have been strong proponent of leveraging new and emerging technologies and of developing novel analytical tools in the service of saving lives throughout my career, so doing this for food safety makes perfect sense to me. Harnessing computing power and applying state-of-the-art data storage and computing to support initiatives are approaches I fully believe in, and they play a key role in the “New Era of Smarter Food Safety”. We will employ such approaches to mine new types and sources of data and we will develop new ways to share those data, allowing us to work together across public and private sector boundaries in the development of new possibilities and solutions for food safety. So, I welcome the opportunity to work on food safety, employing the full range of the most modern and effective scientific and technological resources to strengthen the FDA’s work in this area.

Improving food safety is a big challenge. And, it’s a target that’s constantly in motion. That’s because the world of food supply and demand has been dramatically transformed. The foods we eat increasingly are grown and manufactured in countries other than our own. Other countries now supply more than 50 percent of fresh fruit, almost 30 percent of vegetables, over 90 percent of spices and an estimated 95 percent of seafood eaten by U.S. consumers.

Foods are also being produced … and delivered … differently. For example, consumers are increasingly ordering products on line, taking advantage of new methods of delivery, packaging and communications. I, for one, am looking forward to the day when drones are delivering my groceries.

There’s also a change in demand. Consumers want different foods. Sometimes for reasons of health and nutrition, sometimes just because they can get them. 

Each of these changes and choices can have benefits -- particularly when they support improved health or nutrition. But each can also present the potential for new or changed risks relating to the safety of foods. It’s up to the FDA to make sure we have the tools and expertise to effectively evaluate these changes -- to ensure food safety while not stifling innovation or choice.  

We’re in the midst of a new revolution in food technology. The advances in science and technology that are changing the trajectory in so many different areas of public health, including cancer, are also having an enormous impact on food safety and nutrition. The smarter food safety plan embraces many of these developments. By employing new technologies and gathering more rigorous data and applying it in new ways, this plan will help us develop new and more effective tools to find more solutions to the challenges we face.

This includes accelerating our response time to crises, improving our effectiveness in detecting and preventing outbreaks and ultimately, helping more people and saving lives.

I should point out that using the best available science is not a new approach for the FDA. Since the earliest days of the agency’s food safety oversight authority, we’ve seen advances in science and technology and changes in the food supply. And, as a science-focused organization, we’ve always embraced and relied on these advances to inform our decisions and fulfill our mission to protect and promote the public health.  

To give you just one such example, I call to your attention the case of Burton J. Howard, a microanalyst who joined what was then called the Bureau of Chemistry in 1901. One of the primary goals of the bureau at that time was use regulatory science to develop evidence that would hold up in court. Dr. Howard devised a quantifiable method to detect mold in ketchup. This relied on the exciting new technology back then of a good tabletop microscope. Thanks to his scientific prowess, the government soon was able to invoke his mold count to establish consistently in court a product’s decomposition and therefore it’s level of contamination.

As an agency -- and as food safety professionals -- we will continue to apply scientific diligence and creativity to help determine the most effective ways to apply the most modern technologies and best tools to protect public health and facilitate innovation. Fast forward now to the “New Era of Smarter Food Safety”, which once again sees the agency applying today’s most cutting-edge science and technology to the topic. This is an idea whose time has come.

Our foods and veterinary program has already made enormous strides in strengthening food safety protections through implementation of the landmark FDA Food Safety Modernization Act. The “New Era” builds on the foundation established by FSMA and takes the next important steps to address the safety issues involved in our changing world of food production and delivery. Today’s meeting is a critical part of this process. And your presence is very important to our efforts. Your ideas will inform and shape this blueprint and the development of smarter food safety tools and processes. 

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