July 27, 2008
Safe to Eat?
By Elaine Walker, The Miami Herald
Jul. 27--This summer's salmonella outbreak could go down as the national food supply's biggest unsolved mystery.Instead of a smoking gun, the only clue is a single tainted jalapeno pepper with the rare strain of Salmonella Saintpaul found at a Texas produce distribution center.
The difficulty in finding answers to one of the nation's most complicated and longest-running food-borne-illness cases has turned a spotlight on the beleaguered Food and Drug Administration, as well as the system for protecting the U.S. food supply.
Tomatoes, the original suspect, have been released from questioning but not exonerated. Now federal inspectors have fingered jalapeno peppers from Mexico as a potential source of contamination. But the trail is getting cold, and it's getting hard to find enough evidence to isolate the source of an outbreak that has sickened 1,294 people since April.
Critics say it's evidence of a system that is broken and desperately in need of an overhaul.
"The bottom line is this is not working," said Carl Nielsen, a 28-year veteran of the FDA and former director of import inspections. "There have to be radical changes."
"This is not a matter of throwing a few more million dollars at the problem and a tomatogate wouldn't happen," said Nielsen, who now works as a consultant.
While this salmonella outbreak may be getting more public scrutiny than most, the issues aren't new. At the heart of the problem is a decentralized system for tracking food-borne illnesses that requires coordination of multiple agencies, including the FDA, the Centers for Disease Control and Prevention, and state health departments.
Add to that a multitude of challenges, such as lack of recall authority, funding shortfalls and not enough regulatory control over foreign agricultural practices.
Together, they add up to a prescription for disaster.
"We need to move forward with much-needed modernization of our national food safety laws," said U.S. Rep. Adam Putnam, a Central Florida Republican, who is co-sponsoring new food safety legislation. "These laws haven't really changed since the Eisenhower administration."
But in today's global economy, food is imported from all over the world and shipped cross-country, traveling thousands of miles from the farm to your table.
Industry experts and congressional leaders agree that there must be a uniform standard regarding consumer warnings.
Now, seven weeks after the FDA warned consumers to stop eating certain kinds of tomatoes, the investigation is focusing on jalapeno peppers grown in Mexico. It may have been salsa or a garnish that made consumers sick.
"One of the benefits of having a trace-back system that actually works is that it would have helped to show it was not tomatoes," said Bill Marler, a Seattle attorney who specializes in food safety litigation.
The trace-back process starts with epidemiologists, who must rely on consumers to remember the details of what they ate and when they got sick. But when items such as tomatoes or peppers -- ingredients in many dishes -- are in question, memories are often faulty.
Yet, that's the kind of evidence that the Centers for Disease Control and Prevention uses to draw a scientific conclusion and zero in on the cause of food-borne illnesses. It then becomes the FDA's job to identify the source. The process worked in recent years with salmonella outbreaks tied to spinach and peanut butter, and FDA officials thought it would this time, too.
"The science showed a clear association with tomatoes," Dr. David Acheson, the FDA's associate commissioner for foods, told The Miami Herald. "We have a choice. Do we sit on it and try to chase down a tomato with a positive sample or inform consumers of what we know? It's an approach that has served us well recently. There was no reason to think this time it would be any different. But clearly it was not the sole answer."
Dr. Michael Osterholm, an epidemiologist who has served as a federal government advisor, said part of the problem with this investigation lies in the fact that early on, the FDA did not do trace-back studies on a control group of people who had not gotten sick. This could have helped rule out some food items.
"You've got to be right on these things," said Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. "The issue is: Was the data compiled enough to target tomatoes? That's going to have to be very carefully looked at."
The longer this outbreak goes on without definitive answers, the more consumers continue to get sick. The most recent cases were reported July 10, and the outbreak may not be over. However, the CDC said a little more than a week ago that the number of new illnesses appeared to be decreasing.
Unsure about what's safe to eat, consumers have been staying away from tomatoes. Sales of round and Roma tomatoes, the kinds originally implicated by the FDA, dropped nearly 50 percent in June, according to data collected by The Perishables Group from 15,000 supermarkets nationwide. Overall, tomato sales declined 17 percent.
Those kinds of statistics have taken a toll on Florida tomato growers. They are calling for changes in the trace-back system and demanding compensation from Congress for damage that could be close to $100 million.
"The government was solely responsible for the damages incurred to the industry," said Tony DiMare of DiMare Farms, whose operations stretch across Florida and the country from his base in Homestead. "They've botched the investigation in a bad way, as bad as any investigation they've ever conducted. They have to be held accountable. They not only didn't protect the consumer public, they ruined an industry."
U.S. Rep. Tim Mahoney filed a bill seeking compensation for tomato growers and packers in Florida and across the country. Rep. Debbie Wasserman Schultz, D-Weston, and North Florida Democratic Rep. Allen Boyd, who are on the powerful House Appropriations Committee, are also supporting the effort.
There are also two House hearings set for Wednesday and Thursday to review the issues of fresh-produce trace-back and the handling of the recent salmonella outbreak.
Wasserman Schultz and Boyd have also offered an amendment to an agricultural spending bill that would direct the FDA to study the trace-back program used in the latest outbreak and to base the investigation on samplings from all sizes of tomato operations in Florida, California and Mexico.
"Clearly, more work needs to be done to ensure higher accountability by our federal food safety agencies," Boyd said.
Acheson admits that this outbreak is the "most complicated" one he ever worked on. "It's very unusual for an outbreak tied to a fresh-produce item to go on for this length of time," he said.
Typically, by the time the FDA identifies a fresh-produce outbreak, the crop cycle is winding down and reported illnesses stop on their own.
Among other issues that have complicated this investigation are:
Tomatoes aren't sold with a bar code, like a bag of spinach, that would allow for easier trace-back.
Tomatoes from various farms are mixed together at repacking houses, in order to meet size and color requirements for particular buyers, making it difficult to determine their origin.
Tomatoes don't last long in consumers' homes, so there is no product left to go back and test after someone gets sick.
Acheson also said that sorting through paper sales-and-distribution records at almost every stage along the food chain was challenging.
"It's unjustified to say that the FDA has dropped the ball," Acheson said. "There are problems with the system. The way the system is set up now, it's very slow and laborious. What you need is to move away from paper and into the electronic age. You have to build a system where one piece is connected to the next."
Clearly, that technology already exists. In many cases, all it would take is a bar-code sticker that could allow a tomato or other produce to be tracked from the farm to the table. Companies are even marketing kiosks to be placed in a grocery store, where a consumer could scan a tomato and find out that it was picked March 1 on the hypothetical Joe's Farm in Immokalee.
Critics of the trace-back system said politics has gotten in the way of enforcing regulations already on the books and enacting tougher rules.
The Bioterrorism Act of 2002 requires anyone along the food-supply chain to keep track of both where a product is bought and where it goes next. Many believe that the FDA hasn't used its authority under the law to get quicker and more decisive answers.
"You've got an agency that's reluctant to come down hard on people when they should and also [that] doesn't have the resources," said Joseph Mendelson, legal director of the Center for Food Safety in Washington, D.C. "It's a combination of inadequate resources and incredibly poor execution."
Last November, the FDA unveiled a Food Protection Plan designed to identify potential food safety threats and take action before they impact consumers. But only recently has Congress been asked to fund the plan.
Acheson argues that his agency doesn't have the authority to mandate an effective tracing system. "The industry has the responsibility to produce a safe product and put a system like this in place," he said. "The issue has always been one of cost versus benefit. It may be if the industry looks at the cost of this outbreak, there might be some rethinking."
While the problems with tomatoes have drawn the most attention, it's not the only case in which the FDA's difficulty in determining the cause of a salmonella outbreak has taken a toll on the produce business.
FARM IN HONDURAS
Another recent investigation focuses on a Honduran farm, Agropecuaria Montelibano. After the FDA announced in March that it suspected that a salmonella outbreak in the western United States was linked to the farm's cantaloupes, the United States closed its borders to the product, and the business of the Honduran company, Grupo Agrolibano, plummeted.
Four months later, the FDA has yet to prove that the salmonella originated at the farm. If the import ban isn't lifted soon, Agrolibano executives say, they may go out of business.
That fear also exists among Florida tomato growers. Although Florida's tomato growing season is over, growers want the cloud removed so they can prepare for the fall crop. Tomato plants are already growing in greenhouses, and seedlings will be planted next month.
"I suspect people are going to be fairly conservative," said Reggie Brown, executive vice president of the Florida Tomato Growers Exchange. "You're not going to want to plant any more than you can afford to take the risk on."
Industry experts say that the way food-borne illnesses are dealt with going forward will determine the future of agriculture in the United States.
"If we don't find a better way of handling it, we're going to have a bankrupt sector," said Jim Prevor, editor of Produce Business magazine and writer of the industry blog perishablepunditcom.
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