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FDA Statement

Statement from FDA Commissioner Scott Gottlieb, M.D., on developments in the romaine outbreak investigation, recent outbreaks and the use of modern tools to advance food safety

For Immediate Release:
Statement From:

Being able to identify outbreaks is key to being able to take quick action to prevent additional illnesses and find the source of the contamination. In recent years, the FDA and the Centers for Disease Control and Prevention (CDC) have advanced new tools that make it easier and faster to identify outbreaks of human illness and to link them back to the food source that is the culprit responsible for the illnesses. But our improved ability to spot outbreaks has also caused some to question whether we are experiencing more foodborne outbreaks now than in the past.

The answer to that question is that we don’t believe we are seeing more outbreaks. In fact, we believe food is safer than perhaps ever before and today we’re better at finding outbreaks when they occur.

Over the past few weeks, the FDA, the CDC, and our partners have worked to identify, investigate, address and communicate about several foodborne illness outbreaks. These include outbreaks associated with a popular brand of cereal, vegetable trays, eggs, pre-cut melons, as well as romaine lettuce.

Once these outbreaks were identified, our teams worked quickly to begin determining the source of the contaminated food, identify the safety issues, and provide public warnings and initiate recalls of products. We’ve also worked to understand if these multiple outbreaks, all occurring in a short period of time, reflect a broader trend or a need to reevaluate whether the measures we have in place to prevent and respond to potential contamination events are effective and working the way that they should.

I want to expand on these efforts today, including recent developments in the ongoing investigation of the E. coli outbreak linked to romaine lettuce

The CDC, in their work coordinating with state and local counterparts, have determined that there are no new illnesses occurring in the romaine lettuce outbreak. That means the outbreak can be declared over, but our work to understand this challenging outbreak continues.

The FDA, the CDC, and Arizona state officials continue to analyze samples from the Yuma region collected in early June and initial results are starting to become available. Several environmental samples of canal water in the area have been found to contain E. coli O157:H7 that genetically match the strain of bacteria that caused the outbreak. We have also identified additional strains of shiga-toxin producing E. coli in collected samples, but initial testing of these isolates indicates they are different than the outbreak strain.  

These initial positive samples represent another piece of the puzzle. More work needs to be done to determine just how and why this strain of E. coli O157:H7 could have gotten into this body of water and how that led to contamination of romaine lettuce from multiple farms. We, along with our partners, will continue to assess these findings, their meanings, and determine what additional efforts may help us better understand this outbreak. We are committed to continuing to share updates on our progress.

But it is also important to acknowledge that this breakthrough in the romaine outbreak investigation wouldn’t have been possible without the powerful technologies the FDA, the CDC and our state partners have used.
Scientific advances have made our ability to detect and solve outbreaks much better. As a result, simply counting outbreaks from year-to-year is not an effective way to determine if the number of outbreaks is increasing, decreasing, remaining steady, or to determine whether our food is getting safer or not.

What’s happening is that our ability to identify outbreaks has dramatically improved due to new information technologies and laboratory techniques. This is a view that we share with other experts, including the CDC, who have indicated that as these new methods are employed to protect the public from outbreaks, paradoxically the number of outbreaks may increase since we are now able to identify problems that had previously been invisible to us.

The U.S. has one of the safest food supplies in the world. This is true despite the fact that we also enjoy one of the world’s most abundant, diverse, and complex food supplies.

This is the deliberate result of years of efforts from the FDA, the CDC and the U.S. Department of Agriculture (USDA) to prioritize and modernize our food safety activities at all levels of government, and to adapt our approaches to address a globalized food landscape. The U.S. imports foods from approximately 200 different countries, including 90 percent of our seafood and at least 50 percent of our fruit, depending on the season.

As food moves through supply chain, it often touches many different suppliers and distributors before it reaches the American consumer. This supply chain is even more complex if food is imported.

The breadth of this sourcing and distribution means that when a contamination event happens, an outbreak can affect people from Alaska to Florida and everywhere in between.

Despite our best efforts to ensure the safest food supply possible, foodborne illness continues to occur in the U.S. and elsewhere around the globe. In the U.S., CDC -- the agency that primarily detects multi-state outbreaks of illness -- estimates that foodborne illness affects nearly 50 million people annually, which is about one in six Americans. Of these, an estimated 128,000 people are hospitalized and 3,000 die each year. These numbers are tragically high. While we know we can’t stop foodborne illness completely, these numbers underscore the need for us to do much more. We need to take additional steps, and do it faster, to improve the safety of our food supply.

This is why we’ve focused on developing and using advanced technologies and science to enhance our efforts in preventing food safety problems and improve our response time when incidents occur. These are the tools that are already helping the FDA and the CDC identify more outbreaks of human illness, and trace them back to food when food is the source. We need to invest even more in these efforts, and in the tools to track and trace contaminated food in the supply chain.

The FDA, in concert with the CDC and other partners, are now able to link illness investigations to products in the marketplace more often than ever before, including discovering multistate outbreaks that couldn’t previously be detected.

While there have been many advances over the past years, one of the most powerful of the new technologies we employ is whole genome sequencing (WGS). WGS is a technique that can sequence and determine the entire genetic blueprint of a foodborne pathogen.

By using this technology, public health investigators can link illnesses in different people and locations to reveal outbreaks with a level of precision never previously available. Simply put, this means we’re better at identifying outbreaks and their source.

The FDA has been a leader in applying the use of WGS technology in our fight against foodborne illness and we’ve seen tremendous public health benefit from these efforts.

For example, during the 2015 listeriosis outbreak associated with ice cream, clinical, product, and environmental sample isolates yielded many different pulsed-field gel electrophoresis (PFGE) patterns. WGS analyses demonstrated that isolates from different manufacturing locations were unrelated to one another; however, isolates from each individual manufacturing location were highly related to one another. WGS also aided in identifying historic case-patients for inclusion into the outbreak investigation

Recognizing the value of WGS to more precisely pinpoint the source of foodborne outbreaks, we are joining our partners in ensuring this technology is made more available to states. They are at the front lines of investigating foodborne illness outbreaks. CDC, through its PulseNet system, has provided funding to state public health labs forming a distributed network across the country to perform WGS on pathogens found in samples that are taken from people who present with an illness. Once a cluster of infections is found by whole genome sequencing, public health investigators, or “disease detectives,” across the country then look for a source. These investigations, combining differing lines of evidence, can pinpoint the source of infection.

To these ends, the FDA is conducting WGS on foodborne pathogens identified in foods, manufacturing plants, and other settings. The FDA is  leveraging our GenomeTrakr network, the first distributed network of food labs to use WGS, to provide sequencing capacity in some state food testing laboratories. The FDA’s GenomeTrakr has sequenced more than 183,000 isolates and is regularly sequencing more than 5,000 isolates per month. By comparing the sequences of pathogens found in the samples taken from people who present with a foodborne illness, FDA teams are now able to more precisely link these illnesses to potential food sources.

These modern foodborne outbreak investigation technologies allow us to identify the source of more outbreaks more precisely. This in turn has a positive impact on our ability get this information to consumers who may have contaminated foods in their homes. And to initiate recalls where appropriate. In fact, thanks to advancements in technology and the investigational process, we now begin investigating signals that indicate an ongoing outbreak more quickly than just five years ago.

Our food safety experts in the FDA’s Center for Food Safety and Applied Nutrition, together with our other federal, state and local partners, work to analyze and trace foodborne outbreaks when they occur -- enabling the FDA to take immediate action on unsafe foods. This includes both leveraging our recall authorities to remove the products from sale and alerting people to the risks so that they can protect themselves and their families from products that may be in their homes, workplaces, and schools.

Recalls are critical to getting contaminated products off the market quickly and efficiently. The FDA works with companies on voluntary recalls, and when necessary, mandates recalls to ensure that dangerous products are removed from the market as quickly as possible. When appropriate and available, we’ll release information on retail outlets where contaminated foods may have been purchased if this information can quicken a recall or help a consumer better identify a product. The FDA had previously only done this when product information was difficult to identify to a consumer, but recently for example, the agency released detailed retail distribution information by state for an outbreak linked to pre-cut melon so consumers could better know how to avoid the hazardous recalled food. This follows through on our commitment earlier this year to improve our oversight of food safety and how we carry out our recall activities. We’ll soon issue new guidance on additional information the FDA intends to collect and make available during certain recall notifications. 

The outbreaks that have occurred over the past few weeks highlight the all-too-real consequences of foodborne illness. They also provide a roadmap of where we must head to prevent these things from happening in the first place, and to continue to deliver on our consumer-protection commitments.

By finding these outbreaks and investigating them, we can address the underlying causes and put in place measures to prevent the same problems from happening again in the future.

Owing to our implementation of the landmark FDA Food Safety Modernization Act (FSMA), which represents a sea change in our approach to food safety, we’re transforming the nation’s food safety system by shifting the focus to prevention rather than simply response to foodborne outbreaks. Under FSMA, the FDA has a legislative mandate to require comprehensive, science-based preventive controls across the food supply, including preventive controls for food manufacturing facilities and produce safety standards.

We’re in the early phases of FSMA implementation. We’re making steady and important progress. We recently announced a partnership with our colleagues at the USDA to help ensure the success of FSMA’s Produce Safety rule. And recently I announced that USDA’s harmonized good agricultural practices (HGAP) audit program was fully aligned with FSMA to help growers around the country comply with the Produce Rule requirements.

We’re committed to taking advantage of all our authorities under FSMA. But I also recognize that more efforts and resources are needed to fully implement the FSMA rules at home and abroad, to provide technical support to industry and growers, and to conduct inspections to assure compliance. We’re committed to addressing these issues.

As we apply the new genomic tools to our food safety efforts, we expect we’ll continue to uncover new food safety risks that were previously invisible to us. We’re positioned better than ever before to rapidly respond to these outbreaks so that we can prevent additional illnesses from occurring.

We must never settle for just a small number of outbreaks, or grow comfortable with foodborne illness as a fact of life. We may not stop every outbreak from occurring. But our goal should be to try. And so, we’ll continually to seek out opportunities for improved processes, education, and awareness. And we constantly strive to learn from every outbreak, every issue, so that we might prevent future outbreaks and limit their impact when they do occur.

We continue to strengthen the public health network that makes outbreak investigations faster and more successful. And we’re dedicated to continuously improving these capabilities.

Thanks to the hard work, scientific expertise and diligence of the FDA’s dedicated workforce, we continue to realize meaningful improvements in preventative and response measures.

Our food safety program at the FDA has never been stronger, and we seek to strengthen it further still. It is a key part of the FDA’s public health mission and tightly ingrained in all of our other regulatory commitments. Our agency has a long history of focusing on public health protection through our food safety efforts. Food safety is part of a culture of public health that’s integral to our agency. And it’s a key part of our public health mission. We want food to be safe because it promotes the American industries that produce these products. That’s part of our dedication to these efforts. But first and foremost, we pursue food safety because we seek to protect families.

I remain committed to investing in FDA’s food program, and building on its success -- and to applying the FDA's food safety expertise to protect American families and keep them safe.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.




Peter Cassell

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