FDA Seeks $1.4 Billion for Food-Safety Law as Budget Faces Cuts

E. Coli Bacteria
The enterohemorrhagic E. coli bacteria outbreak in Europe, initially blamed on cucumbers from Spain, was linked to sprouts. Photo: Helmholtz Center for Research on Infectious Diseases/Getty Images

The Food and Drug Administration, charged with preventing E. coli outbreaks similar to the one that sickened thousands in Europe, is trying to wedge $1.4 billion for a new food-safety law into a budget that Republicans have already cut for next year.

A vote in the Republican-controlled House last month to reduce the FDA’s fiscal 2012 food-safety budget by 10 percent to $752 million, the agency estimates, will slow the law’s progress if enacted, say supporters of the January legislation. Representative Jack Kingston, a Georgia Republican who oversees the budgets of the FDA and the U.S. Department of Agriculture, said increases are unneccessary because the food supply is “99.9 percent safe."

That view may be short-sighted, given the type of epidemic in Europe, said Bill Marler, a Seattle attorney who represents food poisoning victims. The outbreak among those who ate German-grown sprouts was deadlier than earlier E. coli epidemics because it combined traits of two strains, raising risks for a potentially fatal kidney complications.

“We have all of the tools to prevent a disaster like Germany’s,” Marler said in an interview. “It’s just a matter of, are we willing to pay for it.”

The FDA is working on rules to reduce contamination risks for fresh produce, required under the law that overhauled the food-safety system for the first time since 1938. The statute would cost $1.4 billion through 2015, the Congressional Budget Office estimates. The House cut would need to be passed by the Senate and signed by President Barack Obama to become law.

Spinach Outbreak

An E. coli outbreak linked to Dole Food Co. spinach five years ago led to 205 illnesses in the U.S. and triggered calls for federal safeguards. Cases since then included a 2008 salmonella outbreak tied to imported peppers, and peanuts contaminated with salmonella that killed at least nine people and sickened more than 700 in 2008 and 2009. Nestle ice creams and Keebler cookies from Battle Creek, Michigan-based Kellogg Co. were among peanut-containing items that had to be withdrawn.

Potential cuts are “enormously worrisome” for officials tracking an increasingly complex global food-supply chain, FDA Commissioner Margaret Hamburg said. “We’re facing a situation where we are being asked to do more with less, and we really feel that this is of enormous concern to the American people,” she said on a June 20 conference call with reporters.

The FDA regulates 80 percent of the U.S. food supply, including produce, while the Department of Agriculture oversees the safety of meat, poultry and egg products.

$152-Billion Cost

Food poisoning strikes an estimated 48 million people in the U.S. each year, leading to 128,000 hospitalizations and 3,000 deaths, according to the Centers for Disease Control and Prevention. Foodborne illnesses cost the nation’s economy about $152 billion a year in health-care expenses and lost productivity, according to a 2010 report by Georgetown University’s Produce Safety Project in Washington.

The CDC has been tracking E. coli since 1993, when the bacteria killed four children and sickened more than 700 people who had eaten undercooked hamburgers from the Jack in the Box fast-food chain, based in San Diego. There have been 234 beef recalls in the U.S. related to the pathogen since then, the CDC said June 7 in a report.

The food-safety law was prompted partly by the 2006 recall of E. coli-tainted spinach from Westlake Village, California-based Dole, the world’s largest producer of fresh fruits and vegetables.

Idaho-grown sprouts caused 21 salmonella illnesses in five states starting in April, the Atlanta-based CDC said June 28.

‘A Wakeup Call’

The unrelated outbreak in Europe, also linked to sprouts, was the world’s biggest E. coli epidemic, sickening more than 4,100 people in 13 European countries and killing at least 49. Though most of the illnesses occurred in Germany, the E. coli strain sickened as many as 18 people in France, the European Centre for Disease Control and Prevention said July 1.

“What’s happened in Europe is a wakeup call,” U.S. Agriculture Secretary Tom Vilsack said June 13, responding to questions after a speech at the National Press Club. “It requires us to be continually vigilant about food safety. It’s an everyday responsibility.”

The produce regulations will deal with sprout safety, said Douglas Karas, an FDA spokesman. Raw and lightly cooked sprouts have caused at least 30 foodborne illness outbreaks in the U.S. since 1996, according to the CDC.

Raw sprouts are riskier than most other types of produce because they are grown in warm, humid conditions where E. coli and salmonella can thrive, according to the federal FoodSafety.gov website. The E. coli strain found in Europe hasn’t been identified in U.S. food sources.

‘Nanny State’

The House-approved spending bill reduces USDA food safety program funding by 3.9 percent from fiscal year 2011 to $972.7 million. Total FDA spending, including its food-safety programs, would be $2.2 billion, a 12 percent decline from fiscal 2011.

The CDC estimate of 48 million foodborne illnesses a year is less than one-tenth of 1 percent of the 340 billion meals consumed annually by 311 million people in the U.S., Kingston, the Georgia congressman, said June 15 on the House floor.

“Something’s working without the FDA and without the USDA and without the nanny state saying, ‘We’re in charge of everything,’” Kingston said.

The law aims to improve coordination among federal and state officials for faster detection of outbreaks and their sources. It may help more agencies emulate states such as Minnesota and Oregon that have been instrumental in solving nationwide foodborne epidemics, said Marler, the Seattle attorney.

Minnesota’s Experience

In Minnesota, a group of investigators traced one of the 2008 salmonella scourges to peanuts and another to Mexican-grown peppers. Oregon identified spinach as the cause of the 2006 E. coli outbreak.

Budget reductions in Minnesota and other states may hinder such efforts and “cut an enormous hole in our food-safety net,” Marler said.

The House-approved budget cuts probably won’t hamper the FDA’s development of produce-safety rules, said David Gombas, senior vice president for food safety and technology at the Washington-based United Fresh Produce Association.

Spending reductions may slow implementation of other aspects of the food-safety law, said Gombas, in an interview.

Rules the FDA develops in the next two years will “shape food safety for the next few decades,” said Scott Faber, vice president for federal affairs at the Grocery Manufacturers Association, a Washington trade group with members including Nestle SA of Vevey, Switzerland, and Northfield, Illinois-based Kraft Foods Inc., the world’s two biggest food companies.

Resources Needed

“The funding needs ultimately will grow, not in fiscal 2012 or 2013, but in subsequent years to meet inspection mandates,” Faber said in an interview. “If the agency doesn’t have more resources further down the road, the FDA won’t be able to retrain its inspectors and fulfill the promise of the food-safety reforms.”

Agriculture Department rules are also evolving, with a proposal submitted to the White House in January to test for E. coli strains beyond the so-called O157 type implicated in the Jack in the Box recall. The plan is being evaluated by the White House Office of Management and Budget, said Alfred Almanza, head of the department’s Food Safety and Inspection Service, in a June 29 interview.

Representative Rosa DeLauro of Connecticut, the ranking Democrat on the House Appropriations agriculture subcommittee, said the White House is dragging its feet. The food safety agency “should not be deterred from its work to protect the public health from known risks in the meat and poultry supply,” she wrote in a June 22 letter to the Obama administration.

Multiple Strains

A government surveillance network that tracks foodborne illnesses in 10 states identified 442 cases of O157 E. coli last year, down from 459 in 2009. The system, known as FoodNet, found 451 cases of other E. coli strains last year, a 71 percent increase over 2009.

The FDA hasn’t decided whether its produce-safety rule will require testing for other E. coli strains, such as the one found in Europe, Karas said.

Tests for non-O157 forms of E. coli aren’t advanced enough to give reliable results, said Jim Hodges, executive vice president of the American Meat Institute, a trade group whose members include Tyson Foods Inc., the largest U.S. meatpacker.

The European outbreak highlighted a need for better science in learning more about the virulence of E. coli strains, not the type, Hodges said.

“There is going to be a lot we can learn from this,” he said.

Fallout From Europe

The food-safety law also calls for FDA pilot programs that will test faster ways of tracing outbreak sources.

“The big thing that I think will come out of what happened in Germany is going to be the pilot projects,” said David Plunkett, a senior staff attorney at the Center for Science in the Public Interest, a public policy group in Washington. The FDA should “look at the German experience and look for the failures and ask, how can we model this so we can see whether or not we can develop a system that will avoid that problem,” he said.

Faster traceability will reduce costs for companies linked to outbreaks, said Erik Olson, director of food programs at the Pew Health Group in Washington.

“The better the traceback system is, the more companies will save when there are recalls,” Olson said. “If they can wall off just a very limited number of shipments that are contaminated, that means the vast majority of the food can continue to be consumed and will not recalled.”

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