FDA Stymied In Push to Boost Safety of Produce

Amid Rise in Outbreaks Of Illness, Agency Urged New Rules, Monitoring

WASHINGTON -- The Food and Drug Administration, under fire for a string of illnesses caused by contaminated vegetables, earlier this year came up with an ambitious, industry-endorsed plan calling for tough new regulations on the handling of fresh produce.

But the plan went nowhere after it got a cold reception from FDA's parent agency, the Department of Health and Human Services. And even today, amid continuing concern about the safety of the nation's food supply, efforts to address the problem remain in limbo.

People close to the FDA say HHS officials led by acting Deputy Secretary Eric Hargan rejected the FDA plan, which was presented in February at HHS headquarters. At the meeting, the FDA warned that its current approach to protecting the safety of fruits and vegetables, which relies on the industry following voluntary guidelines, was failing to stop an increase in foodborne illnesses, according to people familiar with the matter. Those in attendance included Robert Brackett, director of the FDA's Center for Food Safety and Applied Nutrition.

Among other things, the FDA outlined a three-year effort that would pump $76 million into its coffers to monitor produce safety and impose stringent rules on growers and processors to prevent contamination. Such a campaign could cut produce-related outbreaks of illness in half, the FDA officials said.

HHS spokeswoman Christina Pearson said that the February meeting was just a background session, with the FDA presenting "a wide variety of options available to us in our efforts to improve food safety," and didn't require a policy or regulatory decision.

An FDA spokeswoman referred calls seeking comment from Dr. Brackett to David Acheson, who on May 1 assumed the newly created position of FDA assistant commissioner for food protection. Dr. Acheson, who at the time of the meeting was chief medical officer of the FDA's food safety center, didn't attend the gathering but was involved in preparing materials for it.

Businesses often resist new regulations. But in recent months, major food-industry groups, including the United Fresh Produce Association and the Grocery Manufacturers Association, have called for new FDA rules to ensure the safety of fruits and vegetables, an approach they think will be more effective than voluntary measures in bolstering consumer confidence.

"The message to HHS, from the industry, from Congress, is there's urgency for the administration to act," says Tom Stenzel, president of the United Fresh Produce Association.

The HHS meeting came in the wake of an E. coli outbreak in bagged spinach in September that killed three people and sickened more than 200. The FDA said environmental factors, such as wild pigs, may have caused the outbreak but it can't say for sure. The spinach was processed by Natural Selection Foods LLC, San Juan Bautista, Calif.

That was followed by two more E. coli outbreaks involving lettuce that sickened more than 150 people who ate at some of Yum Brands Inc.'s Taco Bell restaurants and Taco John's International restaurants.

E. coli is a common and ordinarily harmless bacteria found in the digestive tracts of humans and livestock. But, if consumed, it can cause kidney failure and even death, especially among children and the elderly. Cooking can kill E. coli and other bacteria, but food experts say that preventing contamination of fresh produce is crucial because it is eaten raw, and the contaminants can't be washed off.

The FDA's Dr. Acheson said that "nothing was ruled in or out" at the Feb. 6 meeting at HHS. In his new position, he plans to develop a strategic plan to improve food safety, and to meet with HHS officials to discuss a range of issues. On fresh produce, he says it is important "to think about preventive controls," but added that he doesn't believe that the government has enough scientific knowledge to impose new regulations on the handling of fresh produce.

The disclosure of the meeting comes as the FDA is under fire from congressional Democrats and consumer advocates on a range of food-safety problems, which go beyond fresh produce. In February, a salmonella outbreak triggered a recall of the popular Peter Pan and Great Value peanut-butter brands, and more than 400 people became ill.

In March, Ontario-based Menu Foods Inc. recalled more than 60 million cans of contaminated pet food after at least 16 pets died. The FDA has blamed the deaths on the chemical melamine. Melamine has since been found in feed for hogs, chickens and fish.

Some food-safety experts think that in the wake of the pet-food scandal and rising concerns about the safety of imported foods, the Bush administration will have little choice but to take a more aggressive stance on food safety.

A spokeswoman at the White House Office of Management and Budget referred questions to HHS, but says the President's Council on Food Safety, which includes representatives from agencies dealing with foods, convened last week to discuss how to improve food safety.

Mr. Hargan, the HHS acting deputy secretary, wasn't available for comment, but Ms. Pearson, the HHS spokeswoman, denied that the department was averse to regulation. "We believe in the importance of a strong, science-based regulatory process and take our responsibility to ensure the safety of foods, drugs and other items FDA regulates very seriously," she says. "The FDA is open to suggestions about its regulatory policies at all times."

The only major food-safety regulations that have been issued during the Bush administration are four rules that were mandated by Congress as part of a bioterrorism law. A 2004 proposal aimed at reducing salmonella in eggs hasn't become a final rule, and the FDA isn't sure when it will.

The administration has been "reluctant to make something mandatory until you can prove that it will be something good. You can't prove that it will do something good until you do it," says Lester Crawford, the former FDA commissioner who supported the egg proposal.

The rising number of produce-related outbreaks has been blamed on the centralization of produce distribution, an increase in imports, the growing popularity of prechopped fruits and vegetables, and environmental factors like animal waste on farms. Fruits and vegetables are now responsible for more large-scale outbreaks of foodborne illnesses than meat, poultry or eggs. The number of E. coli cases involving fresh produce increased from six in 1998 to 356 cases in 2006.

Major players in the fresh-produce industry, hurt by sinking sales after the recent outbreaks, support mandatory steps to prevent accidental contamination. Mr. Stenzel, of the United Fresh Produce Association, said the longer the administration waits to issue rules, the more likely Congress is to do the job itself. Given the choice, he added, "the industry would much prefer the scientists at the regulatory agencies to draft the rules, rather than politicians."

Under the Clinton administration, the FDA imposed rules requiring the seafood and juice industries to take steps to prevent contamination. But in 2004, as the number of foodborne illnesses grew, the FDA wrote a voluntary action plan for the produce industry. In the past three years, it has issued warning letters to the industry, including one to California leafy-greens companies, issued advice to growers and processors on how to prevent food-safety risks and launched an investigation into a disproportionately large number of foodborne illness linked to greens in California's Salinas Valley.

A preventive-control regulation, the type proposed by the FDA at the February meeting, is tailored to each industry and company, and the government's cost stems mainly from auditing companies for compliance. For example, a processor would identify the hazards and take measures to reduce them at critical points, such as ensuring the correct chlorine level in washing water.