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FDA Statement on Vibrio Vulnificus in Raw Oysters
Date:11/13/2009

SILVER SPRING, Md., Nov. 13 /PRNewswire-USNewswire/ -- Several weeks ago, the FDA announced its intent to change, by summer 2011, its policy regarding the post-harvest processing of raw Gulf Coast oysters harvested in the warmer months. The intent of this change in policy, which would affect about 25% of the total annual harvest, would be to substantially reduce the number of Americans who suffer severe and painful illness and death from the Vibrio vulnificus bacteria. The FDA's announced change in policy was modeled on a successful California initiative that was implemented in 2003.

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As a public health agency, the FDA is committed to identifying reasonable and workable approaches to reduce unnecessary suffering and death from preventable causes. The FDA staff work every day with state and local counterparts around the country to stop outbreaks of all types of infectious disease. Illnesses from bacteria like Vibrio vulnificus are particularly important to prevent because they can cause loss of skin, kidney failure, amputations, excruciating pain, and death.

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
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SOURCE U.S. Food and Drug Administration
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