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 FDAs
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
- 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 FDAs Memorandum of Understanding (MOU) with the ISSC should be replaced with an MOU
that restricts the ISSCs 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 states 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.