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 Is Charged With Protecting Consumers From Unsafe Foods

One of the FDA’s key missions is to promote and protect public health by ensuring that foods reaching the market are safe, wholesome, and properly labeled. To that end, Congress empowered the FDA to enforce the Federal Food, Drug, and Cosmetic Act (FFDCA), which prohibits the interstate shipment of unsafe ("adulterated") foods.(53) In addition, the FDA is authorized under the Public Health Service Act (PHSA) to adopt regulations to prevent the spread of communicable diseases, including foodborne illnesses.(54)

Under the FFDCA, a food is "adulterated" when it contains an added "poisonous or deleterious" substance that may make the food harmful to health.(55) There is no doubt that Vibrio vulnificus-contaminated raw molluscan shellfish can harm consumers. Moreover, courts have concluded that a substance is "added" to a food when some demonstrable human intervention is involved.(56) Although Vibrio vulnificus is a naturally occurring bacterium, its levels increase dramatically after the shellfish are harvested during warmer months, due to conditions on the vessel and during transport.(57) In fact, the bacterium can increase 10- to 100-fold in Gulf Coast shellfish from the time of harvest to retail sale, because of lack of refrigeration or other factors related to human intervention.(58) Thus, Gulf Coast shellfish harvested during warmer months pose a threat of adulteration that is significant enough that the FDA should establish regulations to ensure that Vibrio vulnificus-contaminated shellfish are not sold for raw consumption.

The FDA also can use its PHSA mandate to promulgate regulations requiring the shellfish industry to ensure that its products are free from Vibrio vulnificus. In 1987, for example, the FDA used the PHSA to require food producers to pasteurize milk and milk products before selling them to consumers.(59) More recently, in response to food-poisoning outbreaks linked to unpasteurized juices, such as a 1996 outbreak that sickened 66 people and killed one, the FDA published a regulation to require juice makers to use pasteurization or similar processes to significantly reduce pathogen levels in their products.(60)
Other pathogens can contaminate raw shellfish. In 1997, Vibrio parahaemolyticus-tainted oysters caused more than 400 illnesses in 13 states. In 1998, raw oysters transmitted the Norwalk virus to about 300 people in California.

—CSPI, Outbreak Alert!

But instead of using the FFDCA or PHSA to protect the public from Vibrio vulnificus, the FDA in effect delegated its authority for addressing the problem to the ISSC.


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