FDA Hasn't Intensified Inspections At Peanut Facilities, Despite Illness
Friday, April 3, 2009
Despite four outbreaks of salmonella illness from peanut products in the past three years, the federal government has not changed the safety measures required of peanut companies or instructed its inspectors to test for the bacteria.
In all, the outbreaks have killed nine people and sickened more than 1,400.
Although officials at the Food and Drug Administration promised to intensify inspections after a salmonella outbreak caused by Peter Pan peanut butter in 2007 sickened 628 people, the agency did not increase checks or require microbial testing at peanut plants, officials have acknowledged in congressional hearings.
That is still true today, even after Congress and President Obama sharply criticized the FDA for oversight failures leading to the recent outbreak of salmonella illness linked to products sold by Peanut Corporation of America. That outbreak, which began in September and is slowing, has sickened more than 690 people, killing nine, and triggered the largest food recall in U.S. history.
During its investigation of the Peanut Corporation case, the FDA discovered about 20 additional facilities that have been making peanut products without the knowledge of federal regulators. It learned about the facilities because they were buying peanuts from PCA, said Michael Herndon, an FDA spokesman. The agency will not name the 20 facilities or say where they are located, he said, adding that FDA inspectors are planning to visit each site shortly.
"It's a little depressing, but not surprising, that they found another 20 facilities they didn't know about," said Jean Halloran, director of food safety for Consumers Union. She pointed to the fact that unknown to federal regulators, one of Peanut Corporation of America's three facilities had operated in Plainview, Tex., for four years until the outbreak.
Salmonella is the most common food-borne bacteria in this country, with 2,500 strains. Contaminated foods are often of animal origin and moist, such as beef, poultry, milk and eggs. But as early as 1994, federal health officials began to see outbreaks of salmonella illness in people who ate nuts. In 2006, the Centers for Disease Control and Prevention counted three such outbreaks traced to peanuts.
"That's a red flag," said Caroline Smith DeWaal, food safety director at the Center for Science in the Public Interest, a Washington-based health advocacy group, adding that the increase in illnesses from peanuts should have prompted regulators to reexamine whether a threat had emerged in a food previously considered relatively safe.
Every year, approximately 40,000 cases of salmonella illness are reported in the United States. Because many milder cases are often not diagnosed or reported, epidemiologists believe the number of infections may be 30 or more times greater. And while healthy adults usually recover within a few days, the illness can be deadly for children, the elderly and people with weakened immune systems.
The FDA, which lacks enough inspectors to regularly visit food manufacturing facilities nationwide, inspects some peanut processing facilities and contracts with dozens of states to perform inspections on its behalf.
FDA inspectors and state officials under contract are now "being encouraged to look for every opportunity to conduct environmental sampling" of peanut processing facilities to test for bacteria, FDA's Herndon wrote in an e-mail.
They are being told to consider testing the facility or a sample of the product when they observe physical conditions that suggest potential contamination, such as "moisture or pooled water, evidence of cross-contamination, improper cleaning and sanitization practices, a history of positive product samples, recent construction, cracks in floors around processing areas, and evidence of roof leaks above food handling areas," Herndon wrote.
Routine testing is not required, and the decision whether to test is left to the inspector, he said.
Food safety advocates said that microbial testing should be part of regular FDA inspections, and that the agency should mandate that every nut processor develop plans that identify specific contamination risks, spell out the ways it will reduce those risks, and then document those efforts, creating a record available to government regulators. The FDA requires this of seafood and juice producers, a step the agency took in the 1990s after several high-profile contamination cases.
"They definitely should be doing salmonella testing in the environment and in the product," Halloran said.
Last month, the FDA issued "guidance" to food companies suggesting that manufacturers that use peanuts should buy them from processors that have systems to reduce the risk of salmonella. The guidance is only advice and does not carry the legal weight of a regulation.
Issuing guidance to industry does little, DeWaal said. "It's a feel-good exercise for the agency which doesn't obligate anyone to do anything," she said.
About half a dozen food safety reform bills are pending on Capitol Hill. Observers say a bill introduced by Sen. Richard J. Durbin (D-Ill.) has the best chance of passing this session. It would require all manufacturers to develop food safety plans, use federally approved laboratories to test for pathogens, and send those results to the FDA. The bill would also require the FDA to annually inspect facilities that produce "high risk" foods.