Precaution should be watchword of FDA, says IOM

The Food and Drug Administration is not currently equipped to handle food safety problems and needs to switch to a risk based system, argues a report from the Institute of Medicine and the National Research Council.

The committee that wrote the report states that the FDA’s abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hindered by limited resources and a piecemeal approach to gathering and using information on risks.

Tainted peanuts

Calls to overhaul America’s food safety system intensified last year on the back of a spate of multi-state foodborne illness outbreaks. Support from food manufacturers also strengthened after the salmonella outbreak linked to peanut products led to more than 700 illnesses and nine deaths, as well as one of the largest product recalls in US history, at an estimated cost of at least $1bn.

According to figures from the Centers of Disease Control and Prevention, 300,000 people in the US are hospitalized every year due to foodborne illness, and about 5,000 die.

Monitoring impairment

The IOM report notes that given that FDA is responsible for more than 150,000 food facilities, more than one million restaurants and other retail food establishments, and more than two million farms, as well as millions of tons of imports, it lacks the resources to sufficiently monitor the entire food supply.

Committee chair, Professor Robert Wallace, who is based at the College of Public Health at the University of Iowa, said that the FDA “uses some risk assessment and management tactics, but the agency's approach is too often reactive and lacks a systematic focus on prevention.”

Risk assessment

The committee wants the agency to implement a risk-based approach in which data and expertise are marshaled in order to pinpoint where along the production, distribution, and handling chains there is the greatest potential for contamination and other problems.

“The agency would then be able to direct appropriate amounts of its resources and attention to those high-risk areas and increase the chances of catching problems before they turn into widespread outbreaks,” they continued.

Data gathering

In addition, the report calls for the establishment of a centralized food safety data center outside of the regulatory agencies to collect information and conduct rapid assessments of food safety risks and appropriate policy interventions, adding that such a collation house would boost capacity and reduce interagency competition for resources:

“It could also serve as an intermediate step toward consolidating food safety activities within a single agency, which many individuals and organizations have called for,” claims the report.

The report states that the FDA should increase coordination with state and other federal agencies that share responsibility for protecting the nation's food supply, while it calls on Congress to consider amending the Federal Food, Drug, and Cosmetic Act to give the agency the authority it needs to fulfill its food safety mission.

Supply chain

In a report last month, the Government Accountability Office (GAO) noted gaps in the FDA’s food import oversight, claiming that but the agency currently examines less than one percent of imported food.

And GAO maintains that limitations in FDA’s food recall authorities also heighten the risk that unsafe food will remain in the food supply.

Meanwhile Rep. John Dingell (D-Mich) called for action earlier this month on the Senate’s food safety bill, which has seen no attempt to move it forward since it passed from Committee with strong bipartisan support in November 2009.

Legislation held-up

Dingell authored the Food Safety Enhancement Act that passed the House in July. The Senate’s companion bill – the Food Safety Modernization Act – passed the Health, Education, Labor and Pensions (HELP) Committee seven months ago but has stalled as Congress concentrated on health care reform.

And Dingell’s renewed call for action on the bill came in the midst of two new recalls – a recall of salmonella-tainted alfalfa sprouts that has been linked to at least 28 illnesses and six hospitalizations; and romaine lettuce salads that have also tested positive for salmonella.

Dingell said in a statement: “It is unfortunate that we find ourselves reading of more foodborne illness outbreaks that have touched the lives of American consumers. This double whammy should open our eyes to the dangers that exist when it comes to our food supply.

If passed, the bill would require food companies to submit detailed food safety plans, give the FDA the power to order product recalls, and allow it greater access to company records.