DOCUMENTS SHOW FDA AWARE OF PROBLEMS AT PEANUT BUTTER PLANT, SPINACH
FARMS
Monday April 23, 2007
WASHINGTON -- 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.
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 its system needs to be overhauled to meet today's demands but
denied that the agency could 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 brands of pet food.
The outbreaks point to a need to completely overhaul the way the agency does business, said
Robert 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 mean 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.''
Tuesday, the House Energy and Commerce committee will hold a hearing into the unprecedented
spate of recalls, including the more recent contamination of pet food with melamine, which has been blamed for the deaths
of dozens of pets.
"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 Dingell, D-Mich., chairman of the panel. Dingell is considering introducing legislation
to boost the agency's accountability, regulatory authority and budget.
In the peanut butter case, an agency report shows FDA inspectors checked into complaints about
salmonella contamination in a ConAgra factory in Georgia
in 2005. But when company managers refused to provide documents the inspectors requested, they left and failed to follow up.
Earlier this year, a salmonella outbreak 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 in the plant, which is now closed.
The 2005 report shows 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.
"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,'' said ConAgra spokeswoman Stephanie Childs 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 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,
like 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 for 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 and 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 contamination problems in spinach, tomatoes and lettuce,
Congress has voted 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, 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.