The U.S. Food and Drug Administration yesterday unveiled an overview of initiatives to advance regulatory science and help the agency assess the “safety, efficacy, quality and performance of FDA-regulated products.”

The agency’s White Paper was released at the National Press Club in Washington, DC by FDA Commissioner Dr. Margaret Hamburg.  It outlines the agency’s effort to modernize its tools and processes for evaluating everything from nanotechnology to medical devices to tobacco products.

“The field of regulatory science — both the knowledge generated in developing new tools and the tools themselves — has the potential to inform a broad range of health-related advances, involving numerous diseases and conditions,” reads the report.  “The knowledge generated from such studies may well be applicable across entire classes of food and medical products and could help better ensure that such medicines are both safe and effective.”

“Right now, regulatory science is not as robust as it needs to be,” Hamburg said during a question-and-answer session at the National Press Club.  “Part of the challenge is to strengthen regulatory science capacities in the field.”

She also told reporters that “there is no other agency in government that does what we do.  If we can’t do our job and do it well, there’s no one to backstop us.”

That message is underscored in the report, which also states “the effectiveness of FDA’s food safety program depends on the strength and capacity of the science underlying it.”

A section of the report dedicated to food, “Protecting the Food Supply,” outlines current and future agency initiatives to better protect and ensure the safety of the U.S. food supply.

Included as a recent example of advancing regulatory science in food safety is the FDA response to the Gulf oil spill.

“FDA, in concert with state health authorities, was and continues to be responsible for ensuring the safety of seafood caught in the Gulf,” reads the report.  “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.”

The report lists several opportunities for advancing food regulatory science, excerpted here:

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.

The full report is available here.

FDA’s regulatory science initiative is projected to cost $25 million over the next year, part of the Obama Administration’s FY2011 budget request that asked for a 23 percent increase in the agency’s budget.  Since Congress failed to complete a budget this year, the agency’s budget, like most others, will remain flat.