FDA "is incapable of adequately protecting the safety of the food supply."
- From: Tunderbar <tdcomeau@xxxxxxxxx>
- Date: 23 Apr 2007 14:24:24 -0700
http://www.washingtonpost.com/wp-dyn/content/article/2007/04/22/AR2007042201551.html
FDA Was Aware of Dangers To Food
Outbreaks Were Not Preventable, Officials Say
By Elizabeth Williamson
Washington Post Staff Writer
Monday, April 23, 2007; Page A01
The Food and Drug Administration has known for years about
contamination problems at a Georgia peanut butter plant and on
California spinach farms that led to disease outbreaks that killed
three people, sickened hundreds, and forced one of the biggest product
recalls in U.S. history, documents and interviews show.
Overwhelmed by huge growth in the number of food processors and
imports, however, the agency took only limited steps to address the
problems and relied on producers to police themselves, according to
agency documents.
Boys play soccer near a blast wall in Baghdad's Karrada neighborhood.
U.S. forces plan to erect walls and Jersey barriers around at least 10
districts. (Wathiq Khuzaie -- Getty Images)
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Congressional critics and consumer advocates said both episodes show
that the agency is incapable of adequately protecting the safety of
the food supply.
FDA officials conceded that the agency's system needs to be overhauled
to meet today's demands, but contended that the agency could not have
done anything to prevent either contamination episode.
Last week, the FDA notified California state health officials that
hogs on a farm in the state had likely eaten feed laced with melamine,
an industrial chemical blamed for the deaths of dozens of pets in
recent weeks. Officials are trying to determine whether the chemical's
presence in the hogs represents a threat to humans.
Pork from animals raised on the farm has been recalled. The FDA has
said its inspectors probably would not have found the contaminated
food before problems arose. The tainted additive caused a recall of
more than 100 different brands of pet food.
The outbreaks point to a need to change the way the agency does
business, said Robert E. Brackett, director of the FDA's food-safety
arm, which is responsible for safeguarding 80 percent of the nation's
food supply.
"We have 60,000 to 80,000 facilities that we're responsible for in any
given year," Brackett said. Explosive growth in the number of
processors and the amount of imported foods means that manufacturers
"have to build safety into their products rather than us chasing after
them," Brackett said. "We have to get out of the 1950s paradigm."
Tomorrow, a House Energy and Commerce subcommittee will hold a hearing
on the unprecedented spate of recalls.
"This administration does not like regulation, this administration
does not like spending money, and it has a hostility toward
government. The poisonous result is that a program like the FDA is
going to suffer at every turn of the road," said Rep. John D. Dingell
(D-Mich.), chairman of the full House committee. Dingell is
considering introducing legislation to boost the agency's
accountability, regulatory authority and budget.
In the peanut butter case, an agency report shows that FDA inspectors
checked into complaints about salmonella contamination in a ConAgra
Foods factory in Georgia in 2005. But when company managers refused to
provide documents the inspectors requested, the inspectors left and
did not follow up.
A salmonella outbreak that began last August and was traced to the
plant's Peter Pan and Great Value peanut butter brands sickened more
than 400 people in 44 states. The likely cause, ConAgra said, was
moisture from a roof leak and a malfunctioning sprinkler system that
activated dormant salmonella. The plant has since been closed.
The 2005 report shows that FDA inspectors were looking into "an
alleged episode of positive findings of salmonella in peanut butter in
October of 2004 that was related to new equipment and that the firm
didn't react to, . . . insects in some equipment, water leaking onto
product, and inability to track some product."
During the inspection, the report says, ConAgra admitted it had
destroyed some product in October 2004 but would not say why.
Boys play soccer near a blast wall in Baghdad's Karrada neighborhood.
U.S. forces plan to erect walls and Jersey barriers around at least 10
districts. (Wathiq Khuzaie -- Getty Images)
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"They asked for some of our documentation and we made the request to
them that they put it in writing due to concerns about proprietary
information," ConAgra spokeswoman Stephanie Childs said last week. "We
did not receive a written request, . . . they filed the report and
that was that."
Until February of this year. That's when the Centers for Disease
Control and Prevention notified the FDA of a spike in salmonella cases
in states near the ConAgra plant. The agencies contacted the company,
which initiated a recall and shut the plant for upgrades.
Brackett said that if the FDA inspector had seen anything truly
dangerous the agency would have taken further action. But, he said,
the agency cannot force a disclosure, a recall or a plant closure
except in extreme circumstances, such as finding a hazardous batch of
product.
The problem in 2005, he added, "doesn't necessarily connect to the
salmonella outbreak right now. It's not unusual to have it in raw
agricultural commodities."
The FDA has known even longer about illnesses among people who ate
spinach and other greens from California's Salinas Valley, the source
of outbreaks over the past six months that have killed three people
and sickened more than 200 in 26 states. The subsequent recall was the
largest ever for leafy vegetables.
In a letter sent to California growers in late 2005, Brackett wrote,
"FDA is aware of 18 outbreaks of foodborne illness since 1995 caused
by [E. coli bacteria] for which fresh or fresh-cut lettuce was
implicated. . . . In one additional case, fresh-cut spinach was
implicated. These 19 outbreaks account for approximately 409 reported
cases of illness and two deaths."
"We know that there are still problems out in those fields," Brackett
said in an interview last week. "We knew there had been a problem, but
we never and probably still could not pinpoint where the problem was.
We could have that capability, but not at this point."
According to Caroline Smith DeWaal, who heads the Center for Science
in the Public Interest, a consumer-advocacy group, "When budgets are
tight . . . the food program at FDA gets hit the hardest."
In next year's budget, passed amid discovery of contamination problems
in spinach, tomatoes and lettuce, Congress has voted the FDA a $10
million increase to improve food safety, DeWaal said. The Agriculture
Department, which monitors meat, poultry and eggs and keeps inspectors
in every processing plant, got an increase 10 times that amount to
help pay for its inspection programs. The FDA visits problem food
plants about once a year and the rest far less frequently, Brackett
said.
William Hubbard, who retired as associate commissioner of the FDA in
2005 and founded the advocacy group Coalition for a Stronger FDA, said
that when he joined the agency in the 1970s, its food safety arm
claimed half its budget and personnel.
"Now it's about a quarter . . . at a time in which the problems have
grown, the size of the industry has grown and imports of food have
skyrocketed," Hubbard said.
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