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The Raw Oyster Debates. For more than a decade, the FDA has been trying to prevent deaths caused by Vibrio vulnificus bacteria that contaminate raw oysters grown in the Gulf of Mexico. These “flesh-eating” bacteria proliferate in warm months and are especially deadly; they kill half of the thirty or so people who develop infections from them each year. Such people tend to have weakened immune systems or chronic diseases, but often do not realize they are at risk.

In 2001, the oyster industry trade association, the Interstate Shellfish Sanitation Conference (ISSC), promised the FDA that the industry would substantially reduce Vibrio infections in oysters within seven years through a program of voluntary self-regulation and education aimed at high-risk groups. If this program failed to reduce the infection rate, the ISSC agreed that the FDA could require oysters to be treated after harvesting to kill pathogenic Vibrio.14

Treatment, in this case, means postharvest processing through techniques such as quick freezing, frozen storage, high hydrostatic pressure, mild heat, or low-dose gamma irradiation, any of which reduces Vibrio vulnificus to undetectable levels. By most reports, the effect of treatment on the taste and texture of oysters is slight, although raw oyster aficionados argue otherwise. In 2003, California refused to allow Gulf Coast oysters to enter the state unless they had undergone postharvest processing. The result? Sales of oysters remained the same but oyster-related deaths dropped to zero.

In contrast, states that did not require postharvest processing experienced no change in the number of deaths, meaning that the ISSC program had failed. Late in 2009, Michael Taylor, whom we met in chapters 2 and 7, reappeared in his newly appointed position as senior advisor to the FDA. In an almost exact reprise of his 1994 speech to the cattle industry about the need to regulate E. coli in ground beef, he informed participants at an ISSC meeting that the FDA intended to issue rules requiring postharvest processing of Gulf Coast oysters in summer months.15

But less than one month later, the FDA backed off. It said it would postpone the oyster-processing rules indefinitely:

Since making its initial announcement, the FDA has heard from Gulf Coast oyster harvesters, state officials, and elected representatives from across the region about the feasibility of implementing post-harvest processing or other equivalent controls by the summer of 2011. These are legitimate concerns. It is clear to the FDA from our discussions to date that there is a need to further examine both the process and timing for large and small oyster harvesters to gain access to processing facilities or equivalent controls in order to address this important public health goal. Therefore, before proceeding, we will conduct an independent study to assess how post-harvest processing or other equivalent controls can be feasibly implemented in the Gulf Coast in the fastest, safest and most economical way.16

Apparently, fifteen or more preventable deaths every year are not enough to elicit preventive action by industry or the FDA. Despite years of warning and unmet promises, this industry was able to induce Congress to force the FDA to back down, thereby raising uncomfortable questions about the new administration’s ability to improve the safety of the nation’s food supply.

Outbreaks and Major Recalls

During the mid-2000s, the United States experienced an astonishing sequence of foodborne outbreaks, each with unique revelations of safety failures followed by calls for regulation, largely unheeded. Despite lack of recall authority, the FDA and the USDA frequently announced “voluntary” recalls. In July 2009, for example, the FDA announced fifty-six voluntary food recalls or market withdrawals because of health risk or mislabeling. The USDA announced four: pork skins (no inspection) and ground beef and dry milk contaminated with Salmonella or E.