Center for Science in the Public Interest

Death on the Half Shell
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

Executive Summary

Consumers put faith in the government to assure the safety of the food supply, but this report will document how the government has betrayed that trust by allowing a well-known food hazard to sicken and kill consumers year after year.

Virtually all shellfish harvested from the Gulf of Mexico in the warmer months carry Vibrio vulnificus bacteria.(1) Public-health officials estimate that Vibrio vulnificus in shellfish causes around 50-60 serious illnesses each year.(2) Half of the people who develop a blood infection from this hazard die from it,(3) making this one of the deadliest types of food poisoning.(4) Those who are most at risk of developing a Vibrio vulnificus blood infection after eating tainted shellfish include the 12 million to 30 million Americans(5) who have an underlying health condition, such as liver disease, AIDS, or diabetes.(6) Nearly all of the deaths from Vibrio vulnificus-contaminated raw shellfish have involved oysters harvested from Gulf Coast waters.(7)

Public-health officials and the shellfish industry have known about this hazard for over a decade, but have not implemented any effective measures to prevent it.(8) That is because the Food and Drug Administration’s (FDA) feeble food- safety program has given away much of its authority to control shellfish(9) to a group called the Interstate Shellfish Sanitation Conference (ISSC).

The ISSC is a coalition of shellfish-producing states and industry representatives that set state standards for the shellfish industry. The Conference, which was designed to facilitate the interstate sale of raw shellfish, such as oysters, clams, and mussels, lets the shellfish industry play a leading role in setting the policies governing its industry, while excluding consumers and their representatives from meaningful participation in the process. The FDA has allowed the Conference to assume responsibility for setting standards governing hazards, such as Vibrio vulnificus, Vibrio parahaemolyticus, and Norwalk virus, in shellfish products. Today, the same Gulf Coast shellfish industry that has been linked to nearly 150 deaths and hundreds of illnesses over the past 12 years(10) uses the ISSC to prevent urgently-needed public-health protections. This report documents the history of the FDA’s and ISSC’s failure to adequately address the public-health hazard posed by Vibrio vulnificus in raw shellfish.


Conclusions and Recommendations

The story of Vibrio vulnificus is the story of the fox guarding the henhouse. Quite simply, the shellfish industry and its home-state regulators, which dominate the ISSC, have proven that they cannot police themselves. Repeatedly the ISSC has put the short-term financial interests of the Gulf Coast shellfish industry ahead of the well-being of raw-shellfish consumers nationwide. In the end, the Gulf Coast shellfish industry has suffered economically because its products are widely viewed as unsafe.(11)

For its part, the FDA has stayed on the sidelines, seemingly fearful of the $40- million-dollar(12) Gulf Coast shellfish industry and its powerful allies on Capitol Hill. Effective government action could have prevented many Vibrio vulnificus-related deaths and illnesses over the past decade and is still needed to prevent countless tragedies in the years to come.

To protect consumers from the hazards of Vibrio vulnificus-contaminated raw molluscan shellfish, we recommend the following steps:
  • Restaurants, retailers, and shellfish brokers should not buy Gulf Coast shellfish harvested during the months of April to October(13) for raw consumption unless the shellfish are treated to kill Vibrio vulnificus.
  • The FDA should add safety standards for molluscan shellfish to its food-safety regulations.
  • The ISSC should be limited to setting water-quality standards for the shellfish industry.
  • Consumers who want to eat raw bivalve shellfish should ask where the shellfish were harvested. Consumers should not eat raw Gulf Coast oysters, clams, or mussels unless they have been processed to kill the Vibrio vulnificus bacterium.


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