Food safety is one of FDA’s most critical public health priorities. As in other areas, the effectiveness of FDA’s food safety program depends on the strength and capacity of the science underlying it. Although much research on food safety is carried out at universities and in private industry, FDA’s regulatory role creates unique scientific and technological needs and opportunities that can be met only by a robust regulatory science program.
In 2007, FDA’s Science Board warned that a lack of adequate scientific capacity and tools in FDA’s Foods Program was limiting the agency’s ability to protect the nation’s food supply.
What has FDA done?
To meet the challenges of the 21st century food supply, including the dramatic increase in imported foods, FDA has increased its investment and sharpened its focus on the science needed to detect food safety breakdowns and to understand how they occur. Although the ultimate goal is to prevent food safety breaches from occurring in the first place, we need the tools to contain them effectively and efficiently if they do occur. As noted in the example below, these technologies are critical on an ongoing basis and in the event of natural disasters that affect the food supply.
- Development of new chemical tests to assess food safety in the Gulf of Mexico after the Deepwater Horizon Oil Spill
The Deepwater Horizon disaster released in excess of 92 million gallons of oil into the Gulf of Mexico, resulting in devastating environmental damage and concerns about the safety of seafood caught in that area. FDA, in concert with state health authorities, was and continues to be responsible for ensuring the safety of seafood caught in the Gulf. This is accomplished through extensive sampling and testing of seafood harvested from the Gulf and sampled from seafood processing and distribution centers across the nation. At the outset of the spill, a chemical method for measuring for the presence of polycyclic aromatic hydrocarbons (PAH), which are found in significant amounts in crude oil and which contain a number of known carcinogens, was known but required extensive time and effort for sample processing and analysis. The FDA worked diligently to develop a rapid, highly sensitive chemical testing method and is now using this method to test seafood from the Gulf to ensure it is safe for consumption.
What can FDA do with increased investment in regulatory science?
A major focus of FDA’s interest in regulatory science is the development of more rapid and practical methods for detecting microbial pathogens in food and equipping FDA’s labs to test multiple food samples for contaminants simultaneously. FDA must also provide scientific leadership to enhance understanding of the causes of food-borne illnesses so that interventions can be designed and implemented to effectively and feasibly reduce risk.
A number of additional opportunities exist to advance regulatory science to improve food safety:
- Developing effective tools and strategies for sampling, testing and analysis
Tools for the laboratory and for field investigators, such as hand-held devices, are being developed and evaluated to enhance analytical capacity and capability for detecting pathogens of major public health concern such as E. coli O157:H7, Salmonella, and Listeria.
- Tracking Salmonella in the food supply
Salmonella is the leading bacterial cause of food-borne illness in the United States and can originate from many different animal sources. Rapid methods are being developed to speed the detection and investigations of outbreaks. We are using cutting-edge technology to investigate and identify animal sources for human Salmonella infections, as well as antimicrobial resistance and virulence determinants.
- Preventing microbiological hazards
FDA is studying the prevalence and behavior of microbiological hazards in foods to provide the data needed to assess risks, determine the effectiveness of potential control strategies, establish food safety standards and provide practical food safety guidance to industry.
- Responding to food-borne illness
Identifying virulence factors, epidemiological markers and other determinants that influence the ability of pathogenic microorganisms to use foods as vehicles for disease transmission will help enhance epidemiological investigations, intervene earlier in an outbreak and more accurately attribute illness to a product.
- Controlling toxins
FDA is attempting to identify the effect of food production, processing, preparation and use practices on the generation of toxic contaminants, inactivation of naturally occurring toxins and nutrient content.
- Monitoring antibiotic resistance in food-borne pathogens
Ongoing monitoring of antibiotic resistance is central to FDA programs to limit the spread of antimicrobial-resistant food-borne pathogens. The National Antimicrobial Resistance Monitoring System (NARMS) monitors trends in antibiotic resistance among food-borne pathogens from animals (conducted by the U.S. Department of Agriculture), humans (conducted by the CDC) and retail meats (conducted by FDA). Since its inception in 1996, more than 210,000 test results have been added to the NARMS database. All NARMS recovered Salmonella and Campylobacter isolates are compared to human isolates in CDC’s PulseNet database. Expansion of this effort could provide additional critical information about the effect of antibiotic use in animals on resistance in human bacterial strains.
With continued and enhanced efforts in these and other areas of regulatory science, FDA can help provide the knowledge, tools, and scientific leadership needed to improve food safety and protect public health.