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August 6, 2008

The FDA under fire: the fall-out from the salmonella scare

Last week, two days of hearings into the largest salmonella outbreak in the US for ten years brought the issue into sharp relief and uncovered some very serious criticisms made of and by the food standards watchdog. Katy Humphries reports.

Last week, two days of hearings into the largest salmonella outbreak in the US for ten years brought the issue into sharp relief and uncovered some very serious criticisms made of and by the food standards watchdog. Katy Humphries reports.

So far, there have been 1,304 reported illnesses associated with the outbreak of salmonella stpaul, a rare strain of the disease that has hospitalised more than 250 people to date.

While the outbreak has slowed the investigation is ongoing. The source of the outbreak is still unclear: tomatoes were originally implicated and now attention has turned to jalapeño and serrano peppers grown in Mexico.  

The latest Food and Drug Administration (FDA) advice suggests that consumers avoid Mexican-grown jalapeño and serrano peppers and the FDA has lifted its warning on tomatoes. However, sending out mixed messages, the US Centres for Disease Control (CDC) has refused to exonerate tomatoes.

Whether speaking before the House of Representatives or addressing the FDA directly, various consumer bodies have cited the FDA’s failure to pinpoint the source of contamination as proof positive of fundamental flaws in an outdated organisation.

Addressing the House agricultural subcommittee, Jean Halloran, director of food policy initiatives at the Consumers’ Union, warns that the lack of a federal electronic tracking system left investigators wasting time following paper trails.

“The current system, wherein those in the produce industry keep paper records that indicate one step forward and one step back in the supply chain, creates an enormous amount of work for any regulatory agency trying to follow a trail,” Halloran testifies.

Meanwhile, in an open letter to FDA commissioner Andrew von Eschenbach, the Centre for Science in the Public Interest and the Consumer Federation of America write that, if a system to trace produce down the supply chain to the farm existed, investigators would have had an easier time identifying the source of the outbreak.

“Effective traceability labelling must encompass the multiple steps along the path from farm to table, including farm-of-origin, packer, distributor, and retailer,” the groups state. “Such a system should use a standardised code for all FDA-regulated items to streamline investigations and ensure effective record-keeping by all entities along the production chain.”

Indeed, the FDA tells just-food, tracing the source of contamination to a specific point in the supply chain presents myriad challenges that have hampered the investigation.

“There are hundreds, if not thousands, of points down the supply chain – from growing to packing, processing and selling – where contamination could occur. It is not enough to narrow the source of an outbreak down to one particular product: the point at which the product became contaminated must be identified so that we can prevent the spread of the disease,” a spokesperson for the federal agency explains. “This is a time-consuming and costly process.”

Part of the difficulty, the FDA says, is that contamination of produce can come from a vast array of different sources: ranging from pathogens that may be present in the soil, water, or fertilizer, to contamination due to inadequate worker health and hygiene protections, environmental conditions, inadequate production safeguards, and inadequate sanitation of equipment and facilities.

With an eye to updating the methods employed to trace food products, the FDA says that it has reached out to food industry associations and consumer groups in order to understand best practice for traceability. The agency is scheduled to hold a public meeting to discuss how to improve traceability this autumn.

A separate public meeting, set for this month, will consider a food-protection plan. At this meeting the FDA also hopes to look at ways to improve collaboration between federal, state and local partners.

In the wake of the House hearings, the FDA has come under heavy fire for its failure to cooperate effectively with other authorities.

During the course of the hearings, it emerged that when tomatoes grown in Florida and California were a suspected source of contamination, the FDA failed to contact state food safety officials.

“Unfortunately, if FDA chooses to limit the information they share with states, we are likewise limited in how useful our assistance will be to them,” Florida agriculture commissioner Charles Bronson says. “FDA failed to ask states to provide them with information we now know they needed, and we had no way of knowing what kind of data that was without them telling us.”

Inter-agency communication and cooperation, it has been argued, would have been able to inspect, test and clear the California and Florida-based producers of involvement in the outbreak in a shorter space of time.

This has left the Florida and California tomato industries reeling from an outbreak it seems likely they had nothing to do with. Growers in these states, and in the tomato sector as a whole, are now calling for an investigation into the investigation and financial recompense.

Tomato growers are demanding compensation from Congress, with estimates putting the cost of the outbreak at more than US$100m.

In order to address its shortcomings, the FDA has called on legislators to grant it additional funding and strengthen its powers.

Dr. David Acheson, the FDA’s associate commissioner for foods, says that food facilities should have to renew FDA registrations every two years; the FDA should have the authority to accredit qualified third parties to conduct voluntary food inspections; and the FDA should be able to issue mandatory recalls of food products if voluntary recalls are ineffective.

Acheson’s testimony before the House committee also suggests that the FDA needs greater powers to regulate and inspect food imports. The FDA, he says, should be able to refuse food imports if inspection access is delayed, limited or denied.

Over the last ten years, imports of food into the US have risen 40% and now constitute 15% of the country’s food supply.

However, even as the food supply chain broadens, the under-funded agency has reduced its inspection staff, former associate FDA commissioner William Hubbard tells the House subcommittee.

According to Hubbard, the FDA can inspect the 120,000 US food-processing facilities once every ten years. The foreign facilities exporting food to the US “are almost never inspected by the FDA”, he adds.

Another fundamental issue identified during the House hearings is a lack of central control overseeing the safety of food, as dozens of federal, state and local agencies are responsible for safeguarding the US food supply.

As the salmonella outbreak has graphically highlighted, these agencies seem incapable of coordinating their efforts. 

The FDA is ultimately responsible for about 80% of the food supply, while the Department of Agriculture handles the remainder – mainly meat and poultry. Tellingly, the Department of Agriculture has more inspection staff on its payroll than the FDA.

High-profile outbreaks like this latest salmonella scare have attracted the attention of the US public, media and politicians. However, according to information released by the CDC they are just the tip of the iceberg. CDC estimates that each year 76m US consumers become ill due to food contamination, 325,000 are hospitalised and 5,000 die.

Indeed, as Representative Dennis Cardoza, chairman of the agricultural subcommittee comments: “You could describe our current food safety system as ‘outbreak roulette’.”

It is clear that there are gaping holes in the US food safety regime: the question now is how to plug them.

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