By Julie Schmit, USA TODAY
Ga. — When Food and Drug Administration inspectors visited Peanut Corp. of
America's plant here in late 2001, they noticed peanut-processing equipment
had been improperly repaired with duct or cellophane tape.
"widespread" use of tape — some torn — concerned the inspectors
because it could harbor insects, was hard to sanitize and could lead to
President Stewart Parnell, who had taken over the plant in February, said
it was a good thing they hadn't come a couple months earlier, because they
would have seen even more tape then, according to the inspectors' report.
Parnell promised to fix the equipment.
last year — months before a salmonella outbreak was linked to PCA's
products from the plant — a private audit found tape still used on
equipment and to cover wall seams.
matter in food safety, and the story of how PCA came to be held responsible
for one of the nation's largest and most costly salmonella outbreaks is all
about details — lots of them — unseen or unreported or not acted upon until
it was too late.
authorities have begun a criminal investigation of PCA, and the company is
bankrupt. Records produced in the FDA's investigation of PCA and in
congressional hearings on the outbreak portray a company that not only
failed to heed warnings about its deficiencies, but allegedly shipped
products that had tested positive for salmonella after retests were
important, the case reveals a food-safety system in which every key link in
the chain of protection failed, food-safety officials and lawmakers say.
The outbreak "is a poster child for everything that went wrong"
with the USA's food-safety system, says William Hubbard, a former FDA
associate commissioner. "Down the line, you can find flaws and
U.S. food-safety net relies heavily on companies to be good operators. Yet
PCA repeatedly failed to fix problems that were brought to its attention,
according to regulatory records and documents made public in congressional
hearings. Nestlé, for example, twice inspected PCA plants and chose not to
take on PCA as a supplier because it didn't meet Nestlé's food-safety
standards, according to Nestlé's audit reports in 2002 and 2006.
never found anything major wrong with PCA's Blakely plant until after the
outbreak. Then, the FDA found major problems in sanitation, manufacturing
and even plant design.
Nestlé, other PCA customers, including Kellogg, never audited the Blakely
plant themselves. Instead, they selected PCA as a supplier based in part on
an inspection by an auditing firm that was paid by PCA and that rates
almost every client "excellent" or "superior," said
Rep. Bart Stupak, D-Mich., citing his committee's investigation.
outbreak resulted in 700 reported illnesses and may have contributed to
nine deaths. More than 3,600 products were recalled, costing the food
industry hundreds of millions of dollars and signaling to parents that many
of their children's favorites — peanut crackers, cookies, ice cream — could
outbreak also caused heartbreak. One family alleges it stole a mother and a
Christmas from them. Shirley Almer, a 72-year-old cancer survivor, died
Dec. 21 after eating salmonella-tainted PCA peanut butter in an elder-care
facility, her son Jeffrey testified to Congress.
Almer loved this country but was terribly let down by a broken and
ineffective food system," he said at the congressional hearing.
got more than one warning from other companies that its Blakely plant had
Labs, which ran more than 1,600 salmonella tests for PCA's Blakely plant
from 2004 through 2008, found almost 6% positive. It was so many that
Deibel sent PCA's samples to a separate part of its Chicago lab to lessen
chances that they'd contaminate other products, Charles Deibel, the firm's
president, said in an interview.
roasted products such as peanuts, a positive rate above 1 in 10,000 would
be high, Deibel said. Proper roasting kills salmonella with heat. PCA never
asked Deibel to look into the issue, Deibel said.
lab hired by PCA, JLA, based in Georgia, told PCA in 2006 that the Blakely
plant hadn't adequately documented that its roasting killed salmonella,
according to a letter from JLA to PCA that congressional investigators
released. After the outbreak, the FDA noted the same deficiency in its 2009
audited the Blakely plant in 2002 and rejected it as a supplier. Nestlé's
audit report said the plant needed a "better understanding of the
concept of deep cleaning" and failed to adequately separate unroasted
raw peanuts from roasted ones. Having them in the same area could allow
bacteria on raw nuts to contaminate roasted ones, a risk known as
plant wasn't even close to Nestlé's standards, auditor Richard Hutson said
in an interview. Hutson, who now heads quality assurance for several Nestlé
divisions, said he shared his concerns with PCA officials at the time, but
"they didn't pursue it" further with Nestlé, he says.
the outbreak, the FDA found problems at the Blakely plant that were similar
to those found by Nestlé, including inadequate cleaning and storing of raw
and roasted peanuts too close together.
also rejected PCA's Texas plant in 2006.
Deibel, JLA nor Nestlé shared their findings with anyone other than PCA,
which is common industry practice. Congressional lawmakers don't fault
companies for not sharing proprietary data, but some now say that
foodmakers' microbiological test results should be reported to regulators.
the FDA seen PCA's salmonella test results, it might have detected a
problem sooner, said Stephen Sundlof, the FDA's head of its food-safety
center, at a congressional hearing in February.
a lab detected salmonella in PCA products but reported it only to PCA is a
practice that "we can't afford to have in our food-safety
system," said Rep. Bruce Braley, D-Iowa, at the same hearing.
issues noted by Nestlé and JLA, and the frequent salmonella positives found
by Deibel, went undetected by regulators. That's part of what Stupak calls
a "total systemic breakdown" of the U.S. food-safety system.
FDA didn't inspect the Blakely plant itself, after its 2001 check, until
the outbreak. That's not unusual. The agency's inspection staff is so
strapped, it inspects food facilities an average of once every five to 10
years unless they're deemed high risk, which peanut processors were not.
half the FDA's food inspections are done by state inspectors, whose
departments are paid by the FDA to do that work.
the outbreak, and a 13-day inspection of the Blakely plant in January, the
FDA delivered a scathing report. It said the plant didn't clean up after
finding salmonella, had poor controls to prevent contamination and had poor
design to prevent roof leaks.
important, the FDA discovered that PCA shipped products that had tested
positive for salmonella, then negative on a retest. Shipping such product
is "universally condemned," the FDA's Sundlof testified to
Congress, because salmonella can be missed in tests. Products should be
destroyed after one positive result, regulators say.
nine inspections of the Blakely plant — by Georgia agricultural inspectors
in 2006, 2007 and 2008 — found only minor issues, many of which were
quickly fixed, said Oscar Garrison, Georgia assistant Agriculture
commissioner. Two of the checks were done for the FDA.
defends the state inspections as a "snapshot in time." Even
rigorous inspections wouldn't always detect problems if a processor is
intent on "breaking the law," he said.
Stupak, who held two hearings on the outbreak, said the FDA's 2009
inspection report notes numerous violations of good manufacturing practices
that weren't found by the state and which FDA officials later testified
should have been caught.
PCA case has cast a spotlight on the rigor of state inspections done for
the FDA. Some states do a good job; some don't, Hubbard said. The FDA knows
it needs to raise standards, said Michael Taylor, food-safety expert at
George Washington University.
a basic breakdown when an FDA-contracted inspection doesn't detect problems
that seem so obvious," Taylor said.
which closed its three plants after the outbreak, has disputed some of the
FDA's assertions. Parnell, who shares PCA's ownership with an investor
group, worked at its Virginia headquarters. He and other former PCA
managers refused to comment.
plant in Blakely used to employ 50 but now sits deserted. Its paint is
faded and chipped, as if a symbol of the deficiencies the FDA said were
the outbreak hit, PCA supplied 2.5% of the nation's peanut products,
including peanut butter sold to institutions and paste and meal used in
foods made by hundreds of companies.
win customers, Parnell "extolled" the fact that an auditor, AIB
International, had rated the plant as "superior," said King Nut
CEO Martin Kanan at a congressional hearing. King Nut sold peanut butter
under its name that was made by PCA.
rating also satisfied Kellogg, which began buying PCA's peanut paste for
sandwich crackers in 2007. Kellogg CEO David Mackay testified at a
congressional hearing in March that PCA was a "dishonest
supplier" and that Kellogg had done "everything we could" to
had been audited by AIB, "the most commonly used auditor in the
U.S.," Mackay said. PCA had verified that it had fixed issues raised
in the first audit in 2006, Kellogg says. Kellogg visited the plant but
didn't audit. Kellogg also got certificates from PCA — issued by private
labs paid by PCA — saying the product was salmonella-free, Kellogg says.
AIB's rating of PCA has since come under attack, along with the common
practice of foodmakers paying for their own audits.
said congressional investigators found that AIB gives 98% of companies a
"superior" or "excellent" rating. He also said that
e-mails between AIB and PCA point to a relationship that's too cozy to
ensure a tough audit.
lucky guy. I am your AIB auditor," AIB's Eugene Hatfield wrote PCA on
Dec. 22, says an e-mail released by Stupak's committee.
2008, PCA had more than a month's warning before its AIB audit. Former PCA
employees, sanitation director Anne Bristow and Bobby Mallard, said in interviews
that the plant was deep-cleaned beforehand.
days later, it would be back to normal," said Mallard, who ran a
peanut-roasting line. "It was dirty."
last AIB audit, done on one day in March 2008, found few problems.
"Excellent cooperation was received by the writer," wrote
Hatfield in the report. "On some occasions, the items were immediately
refused an interview request but defends its audits on its website. It says
Hatfield had inspected 200 peanut facilities in his career and did a PCA
check that was so detailed he found beetles behind duct tape.
also says the Blakely plant ran for months without a manager in mid-2008,
providing ample time for it to deteriorate between AIB's audit and the
FDA's January 2009 inspection.
also draws criticism from a former food-industry official. Its audit of PCA
was "superficial," said Jim Lugg, former food-safety chief for
bagged salad maker Fresh Express, who reviewed AIB's audit of PCA at USA
example of "shallow treatment of a big issue," Lugg says, is that
the audit notes that PCA had a written program to evaluate suppliers and
had an approved list. But AIB did no further checking of the suppliers.
Years ago, Fresh Express stopped using AIB audits because it found them
inadequate, he adds.
also questions why another audit firm ranked the PCA plant so high even
though the auditor noted many problems.
April 2008, NSF Cook & Thurber inspected the Blakely plant for a
client, which it says wasn't PCA. The audit found so many "minor"
deficiencies at the plant — including use of tape — that the plant ranked
in the bottom 6% of audits done by NSF last year, NSF said in a statement,
adding that it stood "100% behind" the audit.
NSF gave the plant an "opportunity for improvement" rating on
food safety and quality, just below the "acceptable-excellent"
rating. Lugg says that rating appears too high, given the concerns noted in
the audit, including criticisms of the plant's condition, sanitation and
whole idea (of third-party audits) isn't working," says former FDA
official Hubbard. "The inspectors are either telling the client what
they want to hear, or they're doing a perfunctory audit, or they're poorly
while defending its oversight of PCA, now says it will do its own
inspections of high-risk suppliers. It spent less than $20 million on PCA
products. Its cracker recall will cost up to $70 million, Mackay testified.
companies need to do more due diligence on suppliers, food-safety experts
say. "There needs to be a revolution in the supply chain," says
Michael Doyle, director of the University of Georgia Center for Food
the recall, Parnell has been portrayed by congressional lawmakers as a man
most concerned with getting product out the door.
employees also say too little was spent on the Blakely plant. "It was
production, production, production," says Mallard. "Then clean
for 15 minutes."
tell Stewart that this needs to be changed right away," Bristow says.
"He'd say, 'We'll get on it.' It wasn't done."
plant's roof leaked so badly, "It rained in the plant," says
Teresa Spencer. Rainwater can carry salmonella from bird droppings. The
roof leaked even after PCA fixed it, Mallard says.
also left key jobs open. In addition to losing its plant manager in 2008,
it lacked a quality manager for at least four months, NSF's audit says.
side remains untold. At a congressional hearing in February, he invoked his
constitutional right not to testify. His lawyer also refused comment for
this story, citing the criminal probe, as did Parnell's daughter, who did
Almer and his sisters sat behind Parnell in the hearing room.
mother, Shirley, a woman who dragged her grown sons onto the dance floor,
had entered a Minnesota rest home after Thanksgiving to recover from a
urinary tract infection. The day before her expected release, her family
was told she had hours to live. Her mother had lived to be 101.
Parnell refused to testify, Jeffrey, 46, a finance employee for Best Buy,
says he felt rage. It was directed at Parnell but also at the food-safety
system that he says failed his mother.
mom should be here today," he testified.