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

Conclusions and Recommendations

Like the story of the fox guarding the henhouse, the shellfish industry and its home-state regulators have proven that they cannot be trusted to police themselves. Consumers depend on the federal government to intervene when partisan issues might prevent an appropriate public-health outcome. But instead of intervening, the FDA abandoned the transparent notice-and-comment rulemaking process for setting food-safety standards for shellfish in favor of a program dominated by the shellfish industry-the ISSC.

While the ISSC has not ignored the problem of Vibrio vulnificus-contaminated shellfish, most of the measures it has supported place the responsibility for preventing illnesses on consumers, rather than on the industry that is selling these tainted shellfish to the public. Despite years of deaths and illnesses, the ISSC continues to vigorously advocate educational campaigns targeting high-risk consumers. The ISSC has supported only minimal restrictions on industry. For example, the ISSC adopted lax shellfish refrigeration requirements (the time-temperature matrix), and when it became clear that the matrix was not working, the ISSC-with the FDA’s acquiescence-weakened, rather than strengthened, the refrigeration requirements. To date the ISSC has never adequately addressed the Vibrio vulnificus problem.

For its part, the FDA has stayed on the sidelines, seemingly fearful of the $40- million-dollar 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 April to October for raw consumption unless the shellfish are treated to kill Vibrio vulnificus. Consumers should ask restaurants and retailers not to serve untreated raw Gulf Coast shellfish harvested during April to October.
  • The FDA should immediately assert its authority over food-safety standards for molluscan shellfish. The agency should initiate a rulemaking to add safety standards for molluscan shellfish to its seafood Hazard Analysis and Critical Control Point (HACCP) regulation that covers other seafood processors. Among other things, the FDA regulations should establish a performance standard to ensure nondetectable levels of Vibrio vulnificus in molluscan shellfish intended for raw consumption.
  • The FDA’s Memorandum of Understanding (MOU) with the ISSC should be replaced with an MOU that restricts the ISSC’s role to establishing water-quality standards for shellfish harvesting. The MOU also should clarify that the FDA has the sole authority over the list of businesses that are qualified to ship shellfish in interstate commerce.
  • The FDA should begin to audit state inspections of shellfish processing operations to ensure that all relevant regulations are being enforced. If any state fails, the FDA should immediately take over that state’s inspection program.
  • The FDA should direct its research program to study Vibrio vulnificus, including research on the infectious dose, particularly in vulnerable consumers.
  • 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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