(This blog post, published here on Oct. 21, 2014, is the first in a series of five-question interviews the U.S. Food and Drug Administration is doing with stakeholders in government innovation, food/food safety, and other areas that relate to the 2014 FDA Food Safety Challenge.)
Today’s “Five Questions” features Palmer Orlandi, Ph.D., senior science advisor, U.S. Food and Drug Administration (FDA), Office of Foods and Veterinary Medicine (OFVM). Orlandi’s role within OFVM includes ensuring integration and coordination of Center for Food Safety and Applied Nutrition and Center for Veterinary Medicine research and methods development/validation activities with corresponding FDA field laboratories in support of the agency’s public health and regulatory mission.
Can you describe why Salmonella represents such a serious problem in food safety? How does it differ from other pathogens?
While the American food supply is among the safest in the world, the Centers for Disease Control and Prevention (CDC) estimates that one in six Americans is sickened by foodborne illness annually, resulting in about 3,000 deaths each year. It is estimated that the overall negative economic impact of foodborne illness in the United States, including medical costs, quality-of-life losses, lost productivity and lost-life expectancy, may be as high as $77 billion per year. Salmonella represents the leading cause of deaths and of hospitalizations related to foodborne illness. Contaminated produce is responsible for nearly half of foodborne illnesses and almost a quarter of foodborne-related deaths.
The genus Salmonella includes two species: S. enterica and S. bongori. Within these two species, there are more than 2,500 serotypes, with new serotypes being identified every year. Salmonella spp. can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella spp. often experience fever, diarrhea (which may be bloody), nausea, vomiting, and abdominal pain. In rare circumstances, infection with Salmonella spp. can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (e.g., infected aneurysms), endocarditis and arthritis. In addition, direct-human-contact animal foods contaminated with Salmonella spp. pose a significant health risk to humans who have direct contact with the foods at homes, petting zoos, agricultural fairs, or similar venues.
Eggs, egg products, fresh produce, and processed produce account for the majority of food matrices associated with Salmonella contamination. For example, fresh fruits and vegetables destined for domestic and international distribution are grown in large orchards or farm fields. Consequently, there is an increased potential for surface contamination from environmental sources. Fresh produce is by nature a perfect vehicle for a foodborne illness, as it is difficult to remove contaminating pathogens before the consumer eats it. Packaging and further processing (e.g., cutting, slicing, rinsing) under unsanitary conditions provides additional opportunities for contamination of harvested produce. Large-scale outbreaks of Salmonellosis include the nationwide Salmonella Saintpaul outbreak in 2008, the nationwide outbreak from peanut products in 2009, and the nationwide outbreak of Salmonella Enteritidis in shell eggs in 2010 that caused more than 1,600 illnesses. Salmonella outbreak investigations linked to human foods as reported by CDC also included nine in 2011, nine in 2012, seven in 2013, and five so far in 2014.
How would faster detection of Salmonella help FDA fulfill its mission to assure the safety of America’s food supply?
Outbreak investigations involving foodborne illness are a time-sensitive endeavor, particularly for those commodities having a limited/short shelf life such as fresh produce, and are dependent on the gathering of epidemiological evidence to link clinical findings to a putative food source. Detection methods in foods for microbial pathogens in general and Salmonella specifically have largely relied on time-consuming enrichment steps. The results of food matrix analysis are vital to limiting the scope of the outbreak, removing a suspected commodity from the marketplace, and identifying the point source of contamination. Consequently, analytical timeliness is of paramount importance.
Through the development of more rapid and robust detection methods (without sacrificing sensitivity or specificity), we will be better able to limit outbreaks of illness and ensure that any adulterated products are prevented from entering into commerce or, if already there, removed as soon as possible.
What scientific advances do you find particularly exciting as they relate to improving food safety and foodborne pathogen detection?
There are three innovations on the horizon that I believe will have a large impact on protecting the public health.
Hand-held detector technologies are becoming a reality and have the potential to rapidly and reliably perform on-site analyses for the presence of foodborne adulterants. Though there currently are no such field-ready devices to detect microbial foodborne pathogens with the necessary sensitivity, these portable units, when fully developed, are envisioned to perform their analyses outside the laboratory setting, require little or no sample preparation, and provide results in real time.
Whole genome sequencing (WGS) is another innovation that will forever change our approach to foodborne pathogen detection, surveillance and epidemiological investigations. The level of granularity in the data provided by WGS applications, coupled with its growing speed and affordability, will allow the agency to identify incidences of microbial foodborne contamination and link these events to their source with greater speed and certainty.
The third innovation is the incorporation of geographic information systems (GIS), a mapping technology, as a tool to help us understand real and potential pathogen contamination and transmission routes as food moves from farm to table. When coupled with the tracking of environmental data (e.g., seasonality, climate conditions, etc.) and WGS applications to provide epidemiological data, we will be able to better assess risk for foodborne contamination that may be associated with farm-to-table processes.
Why did FDA decide to utilize an open innovation competition to help solve this problem?
FDA realizes that there is great benefit in collaboration and in maximizing resources, manpower, and — most of all — ideas. By reaching out to the general public, academia, and the larger scientific, innovation, and solver communities through this challenge, we are provided with the opportunity to view solutions to our food safety problems through a different lens. It’s a means to consider approaches (and possible solutions) through others’ eyes with technology that we may not have considered applicable. Some of the greatest innovations are born from “outside-the-box” thinking and this is what we hope to achieve. The prize purse doesn’t hurt as an added incentive either.
How do you see open innovation efforts, like the 2014 FDA Food Safety Challenge, impacting how FDA protects America’s food supply?
FDA and our food industry stakeholders share common goals and responsibilities of providing a safe product to our citizens and ensuring the public health. We also share many of the same scientific knowledge gaps needed to fulfill these responsibilities. Specifically, foods are a diverse and heterogeneous matrix and present many challenges analytically to ensuring they are devoid of either chemical or biological adulterants. This first FDA Food Safety Challenge is a means for the agency to achieve a common goal using a new collaborative approach.