Center for Science in the Public Interest

I. Executive Summary
II. Introduction
III. The FDA Plays Politics With Public Health
IV. The FDA is Charged With Protecting Consumers Against Unsafe Foods
V. The FDA Should Establish Standards Through A Fair And Impartial Process
VI. The ISSC Process Is Anything But Fair And Impartial
VII. The Shellfish Industry Has "Captured" The ISSC Process
VIII. How The FDA And ISSC Failed To Protect Consumers
IX. Timeline
X. Conclusions And Recommendations
XI. Endnotes


It was supposed to be a special occasion. Vicki Peal, her husband, and her children decided to take Vicki’s 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. Rosenwald’s 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 couldn’t 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 couldn’t speak without slurring his words. The pain was so excruciating that Mr. Rosenwald couldn’t bear being touched. His family was forced to call 911 for an ambulance.

At the hospital, Mr. Rosenwald’s 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 Rosenwald’s 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 Rosenwald’s 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)


Half of 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 condition.(23)

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)

"FDA’s 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 being treated.(33)

Why is most of the Gulf Coast shellfish industry continuing to put people’s lives at risk when a broad array of solutions is available? Why hasn’t 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 government’s 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 public’s 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 CSPI’s 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.

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