The interplay between federal and state public health authorities was highlighted once again in a Government Accountability Office (GAO) report issued on October 11, 2011. According to the GAO report, the disagreement between the FDA and the Interstate Shellfish Sanitation Conference (ISSC) on a common V. vulnificus illness reduction strategy threatened any progress in protecting consumers of raw oysters. In October of 2009, the FDA proposed changes to its approach stemming from consumption of raw or undercooked oysters, by focusing on elimination rather than reduction.
The FDA would have required that states use post-harvest processing methods, which include a mild heat treatment known as low temperature pasteurization. In addition, during follow-up meetings between the shellfish industry and FDA delegates, the agency considered imposing an annual eight-month ban on raw Gulf Coast oysters. The FDA’s approach was a change from the 60 percent illness rate reduction goal established, with the FDA’s concurrence, by the ISSC in 2001. Although the FDA decided to hold off on the raw oyster ban, the ISSC expressed disappointment that the agency had not followed a 1984 memorandum of understanding between the two entities that outlined cooperative consultation on such matters.
The GAO analysis, conducted from May 2010 to September 2011, noted future difficulties for Gulf Coast states to move towards significantly reducing the number of raw oyster consumption-related illnesses, because the FDA and ISSC could not come to an agreement on the illness reduction goal and strategies to achieve it. Beyond these disagreements on policy, limitations in evaluation metrics employed by both entities also undermined any credibility of progress to date. For example, the ISSC includes California’s results in its illness rate reduction calculation along with Florida, Louisiana, and Texas. The inclusion of California skews the results, because that is the only state that requires all raw Gulf Coast oysters harvested during the summer and sold be processed to reduce the levels of the bacteria to nondetectable levels. Doing so overstates the effectiveness of consumer education and time and temperature controls.
The GAO faulted both the FDA and ISSC for not evaluating the effectiveness of their consumer education efforts since 2004. No direct evaluation of the time and temperature controls implemented in 2010, which called for harvesters to ensure that oysters are cooled to specific temperatures within certain times to reduce bacterial growth, had been undertaken. Moreover, the GAO analysis found it unlikely — even assuming 80 percent compliance in the summer months — that the controls would lead to the level of illness reduction estimated by a model developed by the FDA.
The most recent warning on illnesses associated with raw oyster consumption was issued in late September. Interestingly, the oysters in question were not Gulf Coast oysters, but harvested in waters off of Washington state. More cooperation is needed between federal and state authorities to prevent these foodborne illnesses, but conflicting strategies make such cooperation difficult.