Management problems cited in botulism case
— -- Last July, Food and Drug Administration officials issued a rare warning to U.S. consumers: Botulism toxin was suspected in hot dog chili sauce made by Castleberry's Food.
The botulism outbreak, which would eventually sicken eight and lead to a recall of tens of millions of cans of food, was the first in a U.S.-made canned food in 33 years.
The day before the warning, FDA investigators had begun an inspection at a Castleberry's plant that set off alarms within the agency.
Two 10-foot-tall cookers may not have heated cans enough to kill all bacteria, including those leading to botulism toxin.
The cookers had broken alarms, a leaky valve and an inaccurate temperature device, the FDA said in a previously undisclosed report. USA TODAY obtained a copy from a congressional committee.
The cookers in the Augusta, Ga., plant showed "poor maintenance," and management failed to "correct ongoing deficiencies" in the plant, the report said.
"Failure in management was ultimately the reason for the … botulinum toxin in the cans," according to the report.
The outbreak drove FDA officials to step up inspections at other canneries. In late November, the FDA began inspecting the New Era Canning plant in Michigan, where it discovered botulism spores, a precursor to the toxin, in cans of green and garbanzo beans. No illnesses were reported. New Era recalled 1.2 million cans of vegetables because of the risk.
The recalls worried FDA and industry officials. Botulism toxin — so deadly that it's feared as a bioterror weapon — had been virtually eradicated in the canning industry for decades through time-tested manufacturing processes. The FDA feared some plants had slipped into lax practices that led to botulism-prevention regulations in 1973. On Dec. 21, the day of New Era's recall, the FDA sent a letter warning canneries to "not become complacent."
Donald Zink, a senior FDA food scientist, says a refocus on good manufacturing practices is needed.
"Probably, we've suffered from being too successful," he said in an interview. "Maybe some have gotten a little sloppy."
The FDA's report also underscored the limits of government oversight. The FDA criticized Castleberry's for failing to correct problems, but those problems went undetected by FDA inspectors at the plant five months before the outbreak and by Department of Agriculture inspectors who were in the plant weekly.
Rep. Bart Stupak, D-Mich., who chairs a subcommittee that has held eight hearings on food safety in the past 18 months, says both recalls were "largely a function of careless producers and insufficient regulatory oversight."
"This (canning) process is decades old and well validated. There should be no reason for these hiccups," adds Michael Doyle, director of the Center for Food Safety at the University of Georgia. "It's a matter of properly maintaining equipment and applying proper protocols."
Zink and industry officials say the recalls and FDA warnings caused other companies to tighten safety procedures. "It may be we've seen the worst of it," Zink says. "It may be that we find a few more firms" with problems.



