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Under Pressure, FDA Puts Oyster Policy On Hold

Caving under the weight of a political firestorm over its proposed rule to reduce Vibrio vulnificus poisoning from raw oysters, the U.S. Food and Drug Administration (FDA) announced yesterday it is putting the proposal on hold to “further examine” the rule and its impact on the oyster industry.

Last month, the FDA announced its intention to begin requiring the processing of raw oysters during summer months to limit the risk of Vibrio vulnificis, a deadly bacterium naturally pervasive in Gulf Coast waters during summer months. The rule was expected to take effect in 2011.

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In response to the agency’s announcement, the oyster industry, as well as lawmakers from both sides of the aisle tied to the Gulf Coast, have pushed back against the proposed rule, arguing that it would be devastating to the industry for little public health benefit.

Tuesday, members of Congress from the Gulf Coast met with Mike Taylor, senior advisor to FDA Commissioner Dr. Margaret Hamburg, about the agency’s proposed rule.

Friday, the FDA announced that the policy would be further examined. “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,” said the FDA in a statement. “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,” added the statement, which listed a number of specific steps the agency will take in the coming weeks. 

U.S. Congressman Charlie Melancon (D-LA), who has repeatedly likened the proposed oyster rule to “killing a fly with a sledgehammer,” hailed the FDA’s decision to put the measure on hold. “Now it appears the FDA is coming to realize the harm this ban could have on Louisiana,” said Melancon.

U.S Senator Mary Landrieu (D-LA) also praised the FDA’s decision. “The FDA’s decision today is a major win for our oyster industry and all of Lousiana,” said Landrieu. “By reversing course, the FDA has acknowledged that its original plan was unreasonable and that we need a commonsense approach to protecting the small number of at-risk consumers.”

Consumer advocates were not so thrilled by the agency’s decision. 

“Public health lost out to the politics of special interests with FDA’s announcement today,” said David Plunkett, senior staff attorney at the Center for Science in the Public Interest. “Unfortunately this political victory for the Gulf Coast oyster industry is a health tragedy for their customers.”

Seattle lawyer and food safety advocate Bill Marler is also disappointed the agency backed down, “‘I find it disheartening that the FDA is so clearly placing commercial interest in front of food safety,” said Marler. “Perhaps the FDA should never have passed the ban to begin with. Perhaps in the industry’s mind the number of people who are sickened or die is worth it? However, for goodness sake, once the decision to require a pasteurization step in oysters was made by the FDA, the FDA should have the guts to stick with it.”

The exact timeline of the FDA study on the feasibility of the proposed rule has yet to be determined.

© Food Safety News
  • Anita Grove

    If the FDA and CSPI are so concerned about food safety why not address a products that affect more people like E. coli, BSE and salmonella?

  • Jules Michel

    Anita: The answer is simple. 50% of those infected with Vibrio Vulnificus die. Of the remaining 50%, amputation and lifelong scarring are what a portion are left with.
    The FDA has given industry years to control this and they have failed. The only step taken which has succeeded was California banning these unprocessed oysters.
    Currently, the only reason more have not died is the Gulf Coast shellfish industry is still recovering from the effects of hurricane damage.
    To promote the continued distribution of Vibrio vulnificus in unprocessed raw oysters harvested during the warm months from the Gulf Coast in the name of economics is deplorable.