Kathleen Gensheimer, M.D., MPH, chief medical officer and director of outbreak investigation and response, oversees FDA’s Coordinated Outbreak Response and Evaluation (CORE) Network. She has been on the job since Aug. 1, 2011, when CORE was launched to streamline and strengthen the Food and Drug Administration’s efforts to prevent, investigate and learn from outbreaks of foodborne illnesses.
Gensheimer is responsible for the leadership and management of FDA activities related to outbreaks of illness tied to human or animal food. She is also CORE’s chief spokesperson.
She has had a long career in public health. For 28 years, she was a state epidemiologist in Maine. Epidemiologists investigate the causes of disease, and Gensheimer worked with colleagues in the public and private sectors to control and respond to outbreaks of infectious diseases.
Questions and Answers
Q: How is CORE changing how FDA responds to outbreaks?
A: It’s really a whole new approach to preventing and controlling outbreaks of foodborne illnesses, such as those caused by Salmonella, E. coli or Listeria monocytogenes. It’s a breaking down of barriers, the creation of one work force made up of people with different backgrounds, skills and expertise. CORE is made up of full-time staff dedicated to outbreak activities—which is a major difference from the past.
Q: What happens when you’re not responding to an outbreak?
A: Actually, what I find most exciting is the prevention aspect of the job, which is often based on things we learn during an outbreak. Take last year’s Listeria monocytogenes outbreak in cantaloupe. That was historic because we’d never seen this in whole cantaloupe before. We identified the most likely source—failure to follow safe handling practices in the facility where the cantaloupes were stored and packed, plus improper cleaning and use of equipment. And we shared the lessons we learned with the produce industry—which has been very responsive in an effort to prevent a tragic outbreak of this kind in the future. There was an environmental assessment and an FDA report outlining factors that potentially contributed to the contamination. FDA then met with produce industry officials, and recommended that the industry take appropriate measures to avoid the conditions and practices that led to that deadly outbreak.
Q: What partnerships are particularly important outside FDA?
A: CDC (the Centers for Disease Control and Prevention) and USDA (U.S. Department of Agriculture) are certainly our key federal partners, and one of my priorities is to work very closely with them because our work is very intertwined when it comes to food safety. And we are absolutely dependent on the state and local public health and agriculture officials who begin these investigations. They are usually the first to detect that something unusual is happening.
Q: And within FDA?
A: We work with FDA experts in several of the agency’s centers and offices, especially the Center for Food Safety and Applied Nutrition (CFSAN), the Center for Veterinary Medicine (CVM) and the Office of Regulatory Affairs (ORA). CFSAN works on food-safety issues 24/7. CVM works with us on animal food issues. Most of the people in the field—inspectors, investigators—are ORA staff. Also, when there is a major outbreak and the response has to be ramped up, CORE works with FDA’s Office of Emergency Operations. It’s truly a team effort.
Q: How does FDA reach out to the public during an outbreak?
A: FDA provides information based on the best science and the facts that we know at the time to help people protect themselves. When a specific food is implicated, FDA gives consumers as many specifics as possible about the brand, packaging, lot codes, etc. We understand that news of an outbreak can be frightening to people, and it is our job to provide timely information that they can understand, have confidence in, and use.
Q: What are the difficulties in getting this information out?
A: Understanding the entire chain of distribution is a challenge. It is difficult to convey to the public the many complexities of the food distribution system. There can be hundreds of entities, including wholesalers, brokers, distributors, and retailers. In many cases, the records are not electronic and require manual data collection. And FDA can be limited by its legal responsibility to protect confidential commercial information.
Q: How did your experience as a state public health officer prepare you for this job?
A: In the early days, I just took calls myself about potential outbreaks. I went into the field and investigated them. Because our resources were so limited, I had to reach out to partners both inside and outside of state government. And this is exactly what my role at CORE calls for. I think having a state perspective in a federal agency is very useful.
Q: What do you want consumers to know about FDA?
A: We want them to understand that we are committed to working for a safer food supply. Our goal at CORE is to prevent outbreaks whenever and wherever possible, to act on them when they happen, and to learn from them so that we can prevent them from happening again. People have a right to expect when they go to the grocery store or eat in a restaurant that the food is as safe as it can possibly be.
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
July 24, 2012