Are FDA Scientists Ready for Food Safety Law?

An ambitious new food-safety law aims to shift the focus of the U.S. Food and Drug Administration from response to prevention, but an under-resourced scientific staff—and budgetary restraints—may limit how much FDA can accomplish, experts say.

High-profile outbreaks of food-borne illness over the past several years have left regulators scrambling to recall tainted food—and led to the bill, which President Barack Obama signed into law last week. FDA is responsible for ensuring the safety of the food supply, but the U.S. Department of Agriculture (USDA) handles meat, poultry, and egg products. The law boosts FDA's authority by making its recalls mandatory and requiring all food-processing facilities to come up with hazard-prevention policies. FDA itself will come up with safety standards to be used by fruit and vegetable farmers. Every 2 years, the department must review and rank the risks to the food supply and provide industry with suggestions on prevention.

All this is a considerable new workload for the department's 170 scientists who perform a mix of applied research and assist regulators.

FDA has been criticized repeatedly for not investing more in research. In 2007, a hard-hitting report (pdf) by a subcommittee of the FDA Science Board cited "serious scientific deficiencies" that threaten the safety of food. A report last June from the National Academy of Sciences (NAS) came to the same conclusion and called FDA research "unfocused and fragmented."

Both reports cited problems with FDA's ability to collect and analyze data on food safety. The computer systems used by FDA aren't compatible with those of USDA or the U.S. Centers for Disease Control and Prevention, which tracks human pathogens. FDA also lacks expertise in epidemiology, statistics, and mathematical modeling to evaluate the risks, the NAS panel concluded.

Few of these issues can be solved without more money—the new law is estimated to cost $1.4 billion over 5 years, much of it for hiring new inspectors—and it's not clear how much the new Congress is prepared to offer. "If they don't give them the resources to do this, you're putting FDA in a totally untenable situation," says Robert Buchanan of the University of Maryland, College Park. FDA Commissioner Margaret Hamburg said in a press conference last week that the agency would be able to partner with industry and states to help accomplish some of the goals.