It was supposed to be a special occasion. Vicki Peal, her
husband, and her children decided to take Vickis father, Eric Rosenwald, out for a dinner
of fresh seafood at one of his favorite restaurants near the home they all shared in
Wilton Manners, Florida. Mr. Rosenwalds choice of an appetizer that Friday evening in
1992 surprised his family: he ordered raw oysters on the half shell, which no one had seen
him eat before.
The following Monday, tragedy struck. It began when Mr.
Rosenwald, a robust 80-year-old, started feeling ill and told his daughter that he was
going to take a nap. A few hours later, Vicki rushed home from work when her father
complained that he couldnt get out of bed. At first, they thought Mr. Rosenwald was
suffering from the flu. He took some medicine for his pain and tried to eat some soup. By
late afternoon, however, Mr. Rosenwald was in agony and couldnt speak without slurring
his words. The pain was so excruciating that Mr. Rosenwald couldnt bear being touched.
His family was forced to call 911 for an ambulance.
At the hospital, Mr. Rosenwalds condition grew steadily
worse. Over the next few hours, one lung collapsed and he could no longer speak. Soon his
blood pressure dropped precipitously and, finally, his heart stopped beating. Mr.
Rosenwald died at 1:54 a.m. on Tuesday, just three days after he and his family had shared
their seafood dinner.
It was not until the following day that doctors identified
the cause of Eric Rosenwalds death: the oysters he had eaten were contaminated
with the bacterium Vibrio vulnificus.(14)
By the time Mr. Rosenwald died, the bacteria from the oysters had infected his bloodstream
and spread destructive toxins throughout his body. Eric Rosenwalds story is not uncommon,
because, according to Morris Potter, the former assistant director for foodborne disease
for the Centers for Disease Control and Prevention (CDC), Vibrio vulnificus has
"a predilection for killing."(15) The
course of the disease is so rapid that health-care professionals have little hope of
saving patients like Mr. Rosenwald if they do not quickly diagnose the cause and
administer appropriate antibiotics.(16)
the individuals developing a V. vulnificus blood infection will die as a result.
Sadly, Eric Rosenwald is but one of over
135 people who, according to government data, have died in the past 12 years after
consuming raw shellfish contaminated with Vibrio vulnificus.(17) Though it can cause gastroenteritis in virtually
anyone,(18) the pathogen is most likely to produce
a potentially fatal blood infection in the 12 million to 30 million Americans(19) who suffer from a variety of well-known medical
conditions, such as liver disease,(20) diabetes
mellitus, immune deficiencies (including AIDS), and reduced gastric acidity following
stomach surgery,(21) as well as other disorders
that often go undiagnosed, such as hemochromatosis.(22)
But some victims of Vibrio vulnificus infections have no known predisposing
Although public-health officials have been aware of the
dangers of Vibrio vulnificus-contaminated shellfish since 1976,(24) each year tragedy strikes unsuspecting consumers
of raw shellfish throughout the country. Though some people may realize that eating raw
shellfish can cause food poisoning, few understand the devastating life-threatening
illnesses that can result.(25) In just the past
three years, shellfish contaminated with this pathogen have been linked to at least 50
deaths and many other serious illnesses.(26)
mandate is to protect public health. Consumers should be able to eat oysters without fear
of illness or death."
Those recent deaths and illnesses are
even more tragic when one considers that solutions to the problem have been available for
many years. At least a decade ago, public-health officials had pinpointed
the predominant cause of Vibrio vulnificus infections well enough to recognize a
direct way to prevent those infections. Research had shown that most Vibrio vulnificus
infections were caused by the consumption of raw shellfish harvested from Gulf
Coast waters during the warmer months.(27) The
implication was clear: not harvesting or eating raw Gulf Coast shellfish during the warmer
months would save lives.(28) Yet, despite that
knowledge, government data show that the Gulf Coast shellfish industry actually increased
the amount of shellfish harvested during warmer months.(29)
For its part, federal government-which is charged with ensuring a safe food supply-never
enacted marketing restrictions, required consumer warning labels, or instituted adequate
measures to prevent illnesses and deaths from these shellfish.(30)
More recently, new solutions have emerged that would allow
harvesting during warmer months while still protecting public health. For example, a
Louisiana company developed a mild-heat pasteurization process that kills harmful
bacteria, including Vibrio vulnificus, with little or no effect on the oysters
taste or texture. Other companies have developed additional methods, such as hydrostatic
pressurization and quick freezing, capable of killing Vibrio vulnificus(31) while preserving shellfish quality and only
slightly increasing their market price.(32) A few
Gulf Coast shellfish processors have begun to use these new technologies, but the industry
itself concedes that just one percent of raw oysters harvested from the Gulf Coast are
Why is most of the Gulf Coast shellfish industry
continuing to put peoples lives at risk when a broad array of solutions is available? Why
hasnt our government mandated the application of those solutions? The answer lies in the
ineffectual and largely dysfunctional regulatory framework that the federal government
uses to oversee shellfish safety.
The governments method of regulating the shellfish
industry contrasts sharply with the way that most other food in this country is regulated.
Federal agencies, such as the FDA, traditionally use a system called notice-and-comment
rulemaking when issuing new rules that impose requirements on industries. Under that
system, all stakeholders-from individual citizens to the largest corporations-are able to
participate equally in the decision-making process.
Although shellfish fall under FDA jurisdiction, the FDA
has largely given away its authority over shellfish to a federal-state cooperative program
known as the ISSC.(34) Rather than using
notice-and-comment rule-making, the ISSC uses a decision-making process that is dominated
by the shellfish industry. The system also is compromised by the strong influence of state
regulators, who are unwilling to impose economic costs on their states industries, and
FDA officials, who are more willing to appease the companies and state regulators than to
protect the publics health.
This report examines the inner workings of the ISSC and
explains why this group should no longer be allowed to set food-safety standards for raw
molluscan shellfish. We explore the traditional roles of government and industry in the
regulatory context and how the ISSC structure blurs those lines. In addition, we examine
the longstanding failure of the FDA and ISSC to adequately address the Vibrio
vulnificus problem. Finally, we present CSPIs vision for a regulatory system that
would wrest control from the regulated industry and protective state regulators and enable
all stakeholders-including scientists, public-health officials, and consumers-to
participate in the development of shellfish regulations on an equal footing.
Until the recommended reforms are instituted, consumers
should avoid eating raw Gulf Coast shellfish harvested during warmer months unless the
shellfish have been treated to kill Vibrio vulnificus. If the FDA continues to
rely on the ISSC to set food-safety policy, the senseless tragedy that struck Eric
Rosenwald nine years ago is likely to be repeated again and again.