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

The FDA Plays Politics With Public Health

In 1997, the FDA estimated that between 12 million and 30 million people, as many as one in nine Americans, had medical conditions that made them especially vulnerable to Vibrio vulnificus blood infection.

Vibrio vulnificus is a bacterium that naturally occurs in warm salt waters where some molluscan shellfish are harvested.(35) Vibrio vulnificus causes one of the most severe foodborne infectious diseases.(36) It can induce primary septicemia,(37) a blood infection that leads to death in half of all cases.(38) Those who survive a case of primary septicemia often face amputations and chronic pain. Some people are particularly vulnerable to Vibrio vulnificus blood infections due to underlying medical conditions.(39)

Vibrio vulnificus infections typically are caused by consumption of contaminated shellfish that are raw or undercooked (e.g., lightly steamed). The bacterium may be present in all types of shellfish including oysters, clams, and crabs(40) and cannot be detected by sight, smell, or taste.(41) However, thorough cooking(42) or certain other treatment methods can kill Vibrio vulnificus, making the shellfish safe to eat.


Vibrio vulnificus also can infect an open wound that has been exposed to seawater. However, such wound infections are much less likely to be fatal than the bloodstream infections caused by eating tainted raw oysters.(43)

Scientists have been studying Vibrio vulnificus for more than 20 years.(44) In 1981, the state of Florida began a monitoring and reporting program for Vibrio vulnificus illnesses(45) and, within a few years, a Gulf Coast regional surveillance system was established.(46) Though the surveillance program does not detect all deaths and illnesses linked to Vibrio vulnificus-contaminated shellfish, it does provide important insight into the scope of the problem. Since 1989, at least 263 people are known to have fallen sick from eating raw shellfish contaminated with Vibrio vulnificus; of those, 138 died.(47) The economic impact of those deaths and illnesses is enormous. According to FDA estimates, Vibrio vulnificus imposes costs of at least $120 million each year on the U.S. economy, by far the largest economic impact of any foodborne pathogen associated with seafood products.(48)

Studies of the bacterium’s growth characteristics suggest obvious ways to reduce the number of deaths and illnesses it causes.(49) Vibrio vulnificus thrives in warm marine waters and can reach dangerous levels in the Gulf Coast shellfish harvesting beds, especially during warmer months.(50) Thus, restrictions on the season and location of shellfish harvesting could dramatically decrease deaths and illnesses. Alternatively, post-harvest treatments are available that can kill the pathogen with little or no effect on taste or texture.(51) Unfortunately, no comprehensive solutions have been mandated on a statewide or nationwide basis.(52)

Rather than acting as the guardian of public health, the FDA has, in effect, abdicated its statutory authority to regulate shellfish to the industry-dominated ISSC. And, the ISSC has consistently failed to place the health of consumers ahead of the financial interests of the shellfish industry. As a result, each year Americans die or become debilitated from Vibrio vulnificus-tainted shellfish.

"Negative publicity focused on V. vulnificus has brought into question the effectiveness of the NSSP and the ISSC as an organization."

–FDA, 1994


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