Management problems cited in botulism case
- From: Jim Higgins <gordian238@xxxxxxxxxxx>
- Date: Mon, 30 Jun 2008 07:11:15 -0400
Management problems cited in botulism case
http://tinyurl.com/5pzktr
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.
Castleberry's made fixes at its plant and reopened. New Era also made
changes and received FDA clearance Thursday to resume production. Both
companies say the problems that led to recalls were hard to detect and
not the result of sloppiness.
Food-borne botulism is so rare that only about 30 cases are reported in
the U.S. each year — almost all from home-canned foods, says the Centers
for Disease Control and Prevention. Commercially canned foods are one of
the safest foods because they're cooked long and hot enough to kill
bacteria, unlike fresh produce, in which there is no processing "kill" step.
Even so, botulism is a concern because it's so deadly, claiming 8% of
victims, often because breathing muscles become paralyzed.
The toxin flourishes in the low-oxygen environment of a sealed can or
jar in low-acid foods, such as vegetables, meat, poultry, fish, milk and
olives.
Proper canning prevents botulism. But undercooking, and leaky can seams
that let in bacteria after cooking, may cause it.
'It was mass chaos'
Food safety inspectors from the FDA and Georgia descended on
Castleberry's the night before its July 18 recall, the report said.
Four people in Texas and Indiana had fallen ill, all of whom reported
eating Castleberry's hot dog chili sauce, local and state health
officials had determined.
The recall began with FDA-regulated meatless hot dog chili sauce and
soon grew to 90 products made over two years, including beef stew,
corned beef hash, chili sauce and pet food.
Inside Castleberry's warehouse, investigators found swollen cans, which
can indicate relatively harmless spoilage or deadly botulism. In one
sample of 17 swollen cans, the toxin was in 16 of them, the FDA report says.
Investigators also asked for records, lots of them. None came until the
evening of July 20, three days into the probe, which is when the FDA
gave Castleberry's 24 hours to produce records or face a potential
citation, the report said.
Some key records couldn't be immediately provided because they were
stored on the laptop of the plant's maintenance manager, who was on
vacation, according to the report.
"It was mass chaos," said Christopher Lischewski, Castleberry's CEO, in
an interview.
By following production codes on contaminated cans, the FDA quickly
narrowed its focus to cans made May 7 and May 8 on two of the 100
cookers in the plant.
The FDA said new controls on one cooker were improperly installed in
February and gave off false temperature readings.
In late May, a technician from the cooker's manufacturer, Malo of Tulsa,
noticed the controls were "far out of line," the FDA said in its report,
citing the technician's report.
The FDA also said an employee operating the cooker failed to do required
checks on the cooker's thermometer, the "reference instrument" for
temperature. That's an "egregious" oversight, said canning expert John
Rushing at North Carolina State University. "Everybody knows to do that."
The other cooker that may have produced contaminated sauce had a worn
valve that failed to seal properly, the FDA said. That allowed water to
back up in the cooker, lowering the temperature inside. Zink calls the
worn valve a "maintenance failure."
Alarms or alarm lights, designed to alert operators to problems, on both
cookers were malfunctioning. "Leaking valves and burned out alarm lights
… provide a picture of … poor maintenance and inattention," the FDA
report said.
According to the FDA, the Malo technician said in his report that the
cookers had been well maintained two years earlier but that they were
"maintained poorly now."
Castleberry's was sold in 2005 to Bumble Bee Foods, an operating company
of Canada's Connors Bros. Income Fund.
Some of Castleberry's problems started then, as the 400-employee company
"lost its identity and so did the employees," plant general manager
James Waits told investigators.
An 'almost undetectable' flaw
Castleberry's, which hadn't seen the FDA report until USA TODAY provided
it for comment, disputes the report's assessment of poor management and
maintenance.
Lischewski, who's also CEO of Connors and Bumble Bee, says testing
showed that the leaky-valve cooker was the likely culprit. That problem
was "almost undetectable" unless the valve was taken apart, which wasn't
part of Castleberry's weekly maintenance check, he said.
Neither the Malo technician nor Waits, the plant manager, were fully
informed, he said. The technician wasn't aware of changes Castleberry's
had made in its maintenance program since the company's sale and his
judgment was inaccurate, according to Lischewski. Waits joined the
management team eight days after the recall and made several comments to
the FDA "out of emotion," he added.
Castleberry's said it supplied records to investigators as soon as
possible, given requests from multiple agencies. Paper copies of records
kept by the vacationing manager were at the plant, it said.
"It's a tough-worded report. But I do not believe there was any
sloppiness," Lischewski said. "We believe it was more of a technology
and design issue than an operating issue."
The FDA's Zink said it's not clear which of the two cookers produced
contaminated cans, because the plant's clocks weren't synchronized with
equipment that stamped cans.
"When you have a firm that fails so badly that they produce cans with
Clostridium botulinum … there are invariably multiple process failures,
multiple violations … and failed management systems," Zink said.
Those failures went undetected by two USDA inspectors who were in the
plant several days a week to check meat-containing products.
USDA spokeswoman Amanda Eamich said inspectors check food-safety
controls, but they may not be trained to spot hard-to-detect equipment
problems.
The FDA did a three-day inspection at the plant in February 2007 and
found no major issues. That inspection covered a new line of cookers,
not the ones that led to the recall, Zink said. To inspect all 100
cookers would have taken a month, he added, unfeasible given the
scarcity of FDA inspectors.
'Out of control'
Alarmed by Castleberry's outbreak, the FDA inspected 15 other canneries
that used the same equipment, a step to prevent another outbreak. Only
one sent up red flags: New Era.
In its warehouse, investigators found cans with swells, buckles and
defective seams, according to the FDA's inspection report. New Era was
cited for failing to discover whether its products posed a "potential
public health hazard" and to fix problems.
New Era also did something that Zink said he hadn't seen in 25 years.
Some cans that had buckled after cooking had been pressed back into
shape and sold.
"Debuckling" can mask a "critical defect," Zink said, because buckled
cans may have damaged seams. Canneries typically destroy severely
buckled cans.
"This was a plant that was out of control for some time and dodged a
bullet," said John Cerveny, food microbiologist with NSF-Cook & Thurber,
which audits food plants. He reviewed the FDA report.
New Era didn't undercook, Zink said. The FDA suspects that botulism
spores entered the plant's water via a broken well line and got into
cans through seams while cans were cooled in water.
New Era didn't know how long the water line had been broken, the report
said. Nor did it chlorinate its cooling water, which is commonly done to
kill bacteria, or adequately maintain seaming equipment or monitor
bacteria levels in cooling water, the FDA said.
"When cans buckle and compromise the … seam and you cool them with
unchlorinated water, you really create a disastrous situation," Zink said.
Post-recall reforms
Since their recalls, both companies have made changes.
Castleberry's took suspect cookers out of service. It added backup
valves to others, redesigned controls and retrained workers. The
recall's costs hit $38 million, it said in March.
New Era will check bacteria in water more often and chlorinate cooling
water, even though President Rick Ray said that wouldn't have prevented
contamination in this case. Zink said that's uncertain.
New Era no longer pushes buckled cans back into shape. The company says
only a tiny number were, and that buckles don't pose a safety risk if
seams aren't affected. New Era never intentionally sold cans with
damaged seams, it says, and disputes Zink's opinion that its previous
practices posed a "disastrous situation."
A USDA audit of the plant four weeks before the FDA's inspection found
the plant in compliance, the company says.
New Era is a peak-season employer of 250 in a village twice that size.
The recall was the first for the 98-year-old family-owned company, Ray said.
"We are very concerned about creating safe food, and our track record
shows it," he said.
--
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