ISSC ‘disturbed’ by FDA oyster proposal

Published on
November 2, 2009

The Interstate Shellfish Sanitation Conference (ISSC) is “disturbed” by U.S. Food and Drug Administration efforts to implement post-harvesting controls on raw, live oysters, without the input of the ISSC.

In a letter to the FDA on Monday, J. Michael Hickey, ISSC executive board chairman, said the FDA’s proposal — which could effectively ban raw, live oysters from the Gulf of Mexico for the season — goes against the Vibrio vulnificus policy the ISSC and FDA agreed on in 2001.

“The ISSC is disturbed by the new U.S. FDA policy shift, which could jeopardize the existing Vibrio vulnificus plan and implementation strategy,” said Hickey. “The ISSC voting delegates unanimously disagree with this approach.”

Donald Kraemer, the deputy director for the Center for Food Safety and Applied Nutrition, informed the ISSC in a 16 October letter that the FDA would be reformulating its oyster policy to include post-harvest processing requirements, such as individual quick freezing (IQF), mild heat and low dose gamma irradiation.

“We do not believe measures that reduce but fall well short of eliminating the hazard, such as improvements in refrigeration, are sufficient to meet the purposes of the regulation,” said Kraemer.

However, if FDA officials have concerns about foodborne illness in oysters, they are obligated to communicate concerns with the ISSC before making decisions and new regulations, according to Hickey.

“Should the FDA continue this effort without ISSC support, it is likely that many states will choose not to enforce the federal policy and Gulf states may implement intrastate programs that will lack the consistency and effectiveness to reduce Vibrio vulnificus illnesses nationally,” said Hickey.

Instead of continuing to push its own policy, the FDA should submit a proposal to the ISSC, outlining how its reformulated policy could be integrated into the NSSP [National Shellfish Sanitation Program] ordinance and guidance, he added. The ISSC would review the proposal at its spring and/or fall 2010 executive board meetings.

In addition, the FDA should fund a robust economic analysis study, based on input from the ISSC Economic Analysis Workgroup, said Hickey.

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