A new white paper from the U.S. Food and Drug Administration (FDA) outlining the agency’s new process for assessing the safety of overseas products has one food safety expert questioning the plan’s practicality.
Projected to cost $25 million over the next year, the regulatory science initiative, announced Oct. 6, is designed to enhance the science-based underpinnings of the tools and processes the FDA uses to assess products.
In a section titled “Protecting the Food Supply,” the FDA outlines a number of areas in which increased investment in regulatory science could improve outcomes. They specifically highlight “more rapid and practical methods for detecting microbial pathogens in food and equipping FDA’s labs to test multiple food samples for contaminants simultaneously.”
Other food priorities identified by the report include:
- developing effective tools and strategies for sampling, testing, and analysis, such as handheld devices for field investigators;
- using rapid detection methods to speed up the identification of Salmonella outbreaks;
- identifying virulence factors, epidemiological markers, and other determinants that influence how effectively organisms use foods as disease transmission vehicles;
- monitoring antibiotic resistance in foodborne pathogens;
- identifying how food production, processing, preparation, and use practices affect the generation of toxic contaminants; and
- assessing the behavior of microbiological hazards in the food supply.
“Right now, regulatory science is not as robust as it needs to be,” FDA Commissioner Margaret Hamburg, MD, told reporters at the National Press Club for the release of the white paper. “Part of the challenge is to strengthen regulatory science capacities in the field.”
That could pose quite a challenge, said Purnendu Vasavada, PhD, professor of food science at the University of Wisconsin-River Falls and a member of Food Quality’s Editorial Advisory Board. “Because the FDA’s purview is very broad, overseeing everything from food to tobacco to drugs and medical devices, the only way you can attempt to meet those obligations is to go science-based, so they’re definitely talking about the right kind of thing,” he said.
But Dr. Vasavada questioned how the FDA will achieve the scientific goals it outlines in the white paper with the staffing it currently has. “We need a much larger cadre of trained and experienced people with this kind of scientific expertise,” he said. “That’s the challenge: talent development, recruitment, and retention. Normally, staffing cycles are longer, but they’ll have to make changes in a short period of time to achieve their goals.”
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