Sleuthing, and a Little Help from Consumers, Helps FDA Track Down Bacteria in Flour

By: Stephen Ostroff, M.D., and Kathleen Gensheimer, M.D., M.P.H.

When many people buy flour, they empty it into a canister and throw out the bag. But three people at the center of a recent outbreak of foodborne illness didn’t do that. They kept their flour in the original packaging, and in so doing enabled the FDA to track down what was making people sick.

Stephen Ostroff, M.D.

Stephen Ostroff, M.D., FDA’s Deputy Commissioner for Foods and Veterinary Medicine

The story of the recent recall of 10 million pounds of baking and cooking flour is one in which federal agencies, consumers and the food company – in this case, General Mills – all had a role in doggedly tracking down the source of an outbreak that has made dozens of people across the country sick and getting the suspect product off the market.

It all began with a signal, or more accurately, with multiple signals that were monitored by FDA’s Coordinated Outbreak Response and Evaluation (CORE) network. This team looks for “signals” that may point to a pending outbreak, including reports of human illness from the Centers for Disease Control and Prevention (CDC), FDA-collected data on food samples and inspections, and related information on illnesses and inspections from state and local public health and regulatory agencies.

The signals this time came from CDC, which in February identified a string of illnesses that began in December as an outbreak of infections caused by Shiga toxin-producing E. coli O121. This pathogen is a much less common cause of foodborne illness than its better-known cousin E. coli O157. Investigators began to interview patients about the foods they had eaten in the week before they became ill. But identifying flour as the source of the outbreak was not easy. Initially, it seemed that produce or other foods might be the culprit.

Kathleen Gensheimer

Kathleen Gensheimer, M.D., M.P.H., director of FDA’s Coordinated Outbreak Response and Evaluation (CORE) network

Then there was a break. By April, investigators had found that all of the people interviewed in depth had been baking at home, and many of them said they used Gold Medal flour. Multiple interviewees also mentioned eating raw cookie dough that had been made at home with the flour.

CORE was now faced with the daunting task of proving that specific batches of flour caused the majority of the illnesses. The reports from some patients could not initially be confirmed because key information about the brand and lot numbers was not available – it had gone out in the garbage with the flour bags.

But in the weeks that followed, investigators made two important discoveries:

Three people who had become ill still had the original flour package. Two of the labels showed that the Gold Medal Brand flour had been packaged at a General Mills facility in Kansas City, Missouri, and that they were packaged on consecutive days. The third was made at that plant within a week of the other two.

And the FDA team became aware of illnesses linked to restaurants that would supply balls of raw dough for children to play with. These illnesses were among children who had eaten different meals at restaurants in separate states. The CORE team learned that the flour used by the restaurants during the estimated time of the children’s exposure was supplied by the same General Mills production facility.

The FDA decided not to wait for laboratory confirmation that there was E. coli in the flour before contacting the company. On May 27, FDA and CDC investigators briefed General Mills leadership about the information they had received from patients and on May 31 the firm voluntarily recalled a massive amount of flour — 10 million pounds produced in the Kansas City plant over a three-week period in November and December of 2015.

The FDA continued its analysis of a sample of flour collected from the home of a patient who had provided one of the labels. Laboratory microbiologists at the agency confirmed the presence of E. coli O121 in that flour sample. On June 10, FDA’s whole genome sequencing analysis of that sample also confirmed that the E. coli O121 was closely related genetically to bacteria found in people who had become ill. The final piece of the puzzle was put into place, although the investigation continues to ensure that all contaminated product is off the market.

This was just one of the hundreds of voluntary recalls that the FDA facilitates every year. Going forward, the agency’s compliance and enforcement strategies, including recalls, will get even stronger with the recent establishment of a decision-making body of key senior leaders to identify timely and efficient measures to mitigate public health risks.

Laying the groundwork for a recall can be a complex and lengthy process, with only bits and pieces of information coming in at any one time. But tenacity, collaboration and a willingness to be proactive in protecting consumers, enabled the FDA, its federal, state, and local partners, and General Mills to quickly and efficiently work to recall a potentially dangerous product and keep even more people from becoming ill.

Stephen Ostroff, M.D., is FDA’s Deputy Commissioner for Foods and Veterinary Medicine

Kathleen Gensheimer, M.D., M.P.H., is the director of FDA’s Coordinated Outbreak Response and Evaluation (CORE) network

Getting to the CORE of Foodborne Illness

By: Kathleen Gensheimer, M.D., MPH

Peanut butter. Cantaloupe. Dog food. Tuna. Cheese.

Any of these products might show up on your weekly grocery list.

Each was found to be the source of a foodborne illness outbreak over the past two years.

In the first 17 months since it was launched in August 2011, FDA’s Coordinated Outbreak Response and Evaluation Network (CORE) evaluated 211 incidents of illnesses that were possibly related to FDA-regulated products. After careful analysis, 63 of those incidents were determined to indeed be related to FDA-regulated products and an active CORE response began with one goal: Stop the outbreak.

The highlights of CORE’s work are outlined in our new report entitled “FDA’s CORE: A Food Safety Network 2011-2012.”  As CORE’s director, I could say that I’m proud of what my team has accomplished. But that would be an understatement.

Every day, members of the CORE network at FDA, the Centers for Disease Control and Prevention and state and local agencies, are working to identify, stop and prevent outbreaks. Each outbreak is unique, and so are the results of each investigation. In many cases, though, the network is able to identify, trace and stop an outbreak in its tracks. Contaminated products are pulled out of distribution and removed from grocery store shelves—and hundreds of people may have been spared illness.

CORE introduced a whole new concept into FDA’s response to foodborne illness outbreaks. That is, not just to assemble a team of experts when an outbreak strikes, but to have a full-time, ongoing “core” staff of three teams—Signals and Surveillance, Response, and Post-Response—dedicated respectively to finding the outbreak, stopping the outbreak, and preventing the next outbreak.     

There’s a seamless passing of the baton, and it’s exciting, too. CORE is constantly changing and evolving. Every unique outbreak teaches us new lessons we can apply to the next.

In very short order, CORE proved that FDA could work in close and vital partnership with a huge cast of supporting characters across the country, an extended network of experts from regulatory, public health, agricultural agencies and laboratory staff at the federal, state and local levels. CORE also proved that these partnerships would pay off.

We learn lessons about the science of illness and how it spreads, about the role manufacturers or farmers or packagers or a host of others play. We learn new ways to collect and then crunch the data, and new ways to apply it. We build new relationships and extend our network of experts across the country.

Most importantly, we see first-hand the health hazards that could develop and—if we do our jobs right—we learn how to minimize the chance that they will develop.

So we’re not simply responding to the outbreak. In the intricate chain from farm, to manufacturer, to shipper, to grocer, to your kitchen table, we’re finding ways to help prevent foodborne illness from ever harming you and your family.

Kathleen Gensheimer, M.D., MPH, is Chief Medical Officer and FDA’s Director of Outbreak Investigation and Response

FDA Writing New Chapters in Food Safety History

By: Michael R. Taylor, J.D.

Yesterday, Sunland Inc. entered into a court ordered agreement imposing requirements that must be complied with if the company is to operate. This consent decree follows FDA’s suspension of Sunland’s food facility registration in November as a result of evidence linking Sunland to an outbreak of Salmonella Bredeney that sickened 42 people in 20 states, as well as the company’s history of violations. The company was barred from distributing food in intrastate or interstate commerce while its registration was suspended. 

Mike Taylor, J.D.Yesterday’s consent decree may be seen by some as a final step in the process, but at FDA we see it as a beginning. Certainly, it is a new beginning for the company, which must correct the problems identified during recent FDA inspections before being allowed to market its nut butter products. More broadly, though, it is the beginning of a new chapter in FDA history.

With the suspension of Sunland’s food facility registration, for the first time FDA was, in effect, able to independently prevent a company from distributing food that could have caused harm to consumers. This was our first use of this new authority granted by the FDA Food Safety Modernization Act (FSMA), and it will be an important tool for FDA to use in the future to ensure the accountability of companies for the safety of the food they produce. 

Under the decree, Sunland must hire an independent sanitation expert to develop a program to ensure products are produced in a sanitary way and according to good manufacturing practices. The company must also conduct environmental testing to ensure that disease-causing bacteria aren’t present in its facility or in its final food products. FDA will evaluate the programs Sunland sets up, and will not allow the company to operate its peanut butter plant until we determine that its products can be safely produced. 

Paving the way for this new beginning of accountability for food safety was the work of the many employees from FDA and CDC, and state and local governments, who responded to and investigated this outbreak. The work done on this investigation was outstanding. Within days of being notified of the outbreak, our Coordinated Outbreak Response and Evaluation (CORE) network was making headway on the investigation. A link was made between the illnesses and the product and its manufacturer, and our investigators in the field ramped up their on-going investigation of Sunland’s facility to find the source of the outbreak.  

I also think that FDA’s first use of the suspension authority provided by FSMA demonstrates the promise that FSMA itself holds in all its aspects. The suspension of Sunland’s registration demonstrates FDA’s new enforcement tools, but we are also working on other new preventative tools as well. 

As I said earlier, we are writing new chapters in the history not just of FDA, but of food safety. Our response to the recent Salmonella Bredeney outbreak related to peanut butter was a fine example of our newest innovations, like CORE, and using our authority to suspend a registration. But there is still more to come.

Michael R. Taylor, J.D., is Deputy Commissioner for Foods and Veterinary Medicine


Meet the Men and Women of CORE—FDA’s Outbreak Teams

By Kathleen Gensheimer, M.D., M.P.H.

Too many people die or become very sick after innocently eating a food that is contaminated with bacteria, such as Salmonella, Listeria or E. coli. FDA is taking innovative steps to prevent this from happening.

A year ago, FDA changed direction in its approach to outbreaks of foodborne illnesses. Last August, FDA launched the Coordinated Outbreak Response and Evaluation (CORE) Network, a full-time staff working with counterparts in local, state and federal agencies to investigate, control and prevent these outbreaks. Previously, FDA staff from across the agency would be pulled in on temporary assignments to combat an outbreak.

Kathleen Gensheimer, M.D., M.P.H.During CORE’s first week on the job, it came face-to-face with one of the deadliest outbreaks in this country in decades—Listeria monocytogenes in cantaloupes. Each of the CORE teams—a mix of outbreak veterans and new additions from across FDA—swung into action to identify the source and get the product off the market.

It was trial by fire—and only the first one. By the end of their first year, the CORE teams would deal with major outbreaks involving frozen tuna used in sushi, sprouts, frozen oysters and Turkish pine nuts. They would also face human illnesses linked to the handling of contaminated pet food.

Starting today, FDA will be issuing a series of Consumer Updates, beginning with an overview, that explains how CORE works, what it has accomplished, and what challenges it faces. Look for upcoming articles that feature each of the three CORE teams:

  • Signs and Surveillance: Finding the outbreak.
  • Response: Stopping the outbreak.
  • Post-Response: Preventing the next outbreak.

These articles will introduce you to the men and women of CORE. They come from different backgrounds, and include epidemiologists, veterinarians, public and environmental health specialists, and consumer safety officers. FDA is far more than a name, a group of buildings, or its inventory of equipment.  FDA is its people. People with families like yours. People just like the ones you’ll meet in these stories. This is not just a job to them. It is their mission, and that mission is to keep you and your family safe.

Kathleen Gensheimer, M.D., MPH, is Chief Medical Officer and FDA’s Director of Outbreak Investigation and Response


FDA’s Dr. Roberta Hammond: On the Trail of a Salmonella Outbreak

Bringing a wealth of experience in food safety work — from fresh foods to inspecting restaurants — and years of experience coordinating investigations of food and waterborne disease outbreaks for the Florida Department of Health, Roberta Hammond, PhD, RS, joined FDA’s Center for Food Safety and Applied Nutrition (CFSAN) almost two years ago. At the time of this interview, Dr. Hammond was into her third week as Agency Incident Coordinator for the Salmonella Bareilly Incident Management Group (IMG), tracking the source of a recent outbreak of Salmonella infections.

FDA Voice:  Dr. Hammond, thank you for meeting with us during your hectic day.  Can you tell us about this recent salmonella outbreak?  How are things going?  Do you know what caused it yet?  How many people have been affected?

Roberta Hammond, PhD

Dr. Hammond:  Well, we began tracking this outbreak in early April.  So far, we are aware of 148 affected individuals, with 21 hospitalizations.  We’re always concerned when food makes someone sick, but so far in this outbreak there have been no deaths, thank goodness.  Our field investigators have led us to frozen, raw, ground tuna that was used in sushi and possibly other sushi-related dishes.  The source appears to be a company in India that supplies mostly restaurants with this product.  We had a real breakthrough on this investigation — sometimes they are inconclusive, or we never find the source. 

Nevertheless, the outbreak has presented its own set of challenges.  Most of the identified cases were along the Eastern seaboard of the US, with a few in Texas and a few as far west as Missouri.  Strangely, there is no evidence of Salmonella Bareilly on the West Coast or in Hawaii, which is interesting because in the past, we’ve found those areas to have the highest concentration of people who eat sushi.

FDA Voice: You are the Agency Incident Coordinator for this particular Incident Management Group. What does that entail?

Dr. Hammond:  FDA has an excellent incident management process, with an established structure, a clear set of procedures, and an established chain of command. The Office of Crisis Management (OCM) is our focal point for coordinating responses to natural emergencies or emergencies like the Gulf Oil Spill.  FDA’s Coordinated Response and Evaluation Network, what we call CORE, is an agency outbreak-related activities network that was launched in 2011.  CORE typically receives the first news of a human or animal food incident.  CORE begins the investigation, and if the incident begins to escalate through a broader scope, greater severity, increased number of illnesses, or rise in deaths, we have the option to establish an Agency Incident Management Group, or IMG — this is the first IMG activation since CORE’s launch.  If OCM’s Emergency Operations Center approves the formation of the IMG, most of the staff in CORE who have been working on the issue move into the Agency’s IMG center.  Having the multidisciplinary team members working together in the same room enhances rapid information exchange and provides the group with additional operational support so the investigators can focus on their individual tasks.

We start by looking at the places where people think they may have eaten food that made them ill.  From there, we use invoices and other records to trace the suspect food back to suppliers and then to where the food was produced.  State and local health officials and FDA field staff do this work.  They also collect samples of the suspect products that are tested for the presence of the pathogen –the infectious agent suspected of making people sick. For Salmonella Bareilly, we drew on the expertise of more than 60 trained and experienced investigators in 7 FDA district offices and 20 states and the District of Columbia.

The investigation involves close coordination with FDA partners, with Federal partners like the Centers for Disease Control and Prevention, with our State partners, and anyone else who needs to be pulled into the collaboration. FDA’s response is a well-oiled machine, if I may use a well-worn analogy. 

FDA Voice:  What is your specific role during this emergency?

Dr. Hammond:  I help set up the IMG investigative team and then get out of the way.  This is the first time I have coordinated a major outbreak within the Agency IMG structure, and I’m very impressed — the staff at the Emergency Operations Center are outstanding at what they do as are the CORE staff.  I try to stay in the background, making sure the information gets to everyone who needs it.  I see to it that people have what they need to do their jobs.  And I watch for burn-out.  I am also the primary IMG spokesperson on any calls with other Federal agencies and States, and I provide information to FDA leadership. I’d say one of my most important roles is to listen.

FDA Voice:  Can you tell us what a typical IMG day looks like, if there is such a thing?

Dr. Hammond:  First comes the daily kick-off meeting.  I then meet with the section chiefs — planning, operations, logistics, and others.  Then we watch over the work of the nearly 30 people who are tracking down clues about what might be the cause of the outbreak and identifying the steps we need to take to keep the food supply safe.  I attend meetings and conference calls whenever needed, including meeting with the Agency Executive Group and FDA’s senior leadership to consider strategic options for the short and the long term.

FDA Voice:  Dr. Hammond, when does an IMG deactivate?

Dr. Hammond:  You can tell when things begin to wind down. People are no longer working at breakneck speed.  Once the IMG has slowed and no longer requires the intense level of activity, it is transferred back to the CORE staff who tie up the loose ends.  I will sit down with the IMG Section Chiefs and do what’s commonly referred to as a “hot wash.”  We carefully go over everything that has happened — the planning, the logistics, the operations, the communications.  We hope to glean any new understandings that can help us the next time.  And, whether another foodborne illness or a natural disaster, we know there will always be a next time.