FDA to change its policy regarding the post-harvest processing of raw Gulf Coast oysters

FDA Statement on Vibrio Vulnificus in Raw Oysters

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.

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 be feasibly implemented in the Gulf Coast in the fastest, safest and most economical way.

While this study is ongoing, the FDA will continue to reach out to state authorities and the Gulf Coast industry to discuss their concerns about the agency's policy and measures the industry is pursuing to make oysters safer.  The FDA is committed to assisting local farmers in the implementation of post-harvest processing through all possible means.

The agency looks forward to working with Gulf Coast officials and industry to accomplish the goal of protecting consumers from Vibrio vulnificus in a manner that is feasible and minimizes impacts on the oyster industry.

Some actions that the FDA will undertake over the next weeks and months include:

#1.       Continuing to discuss future collaboration with the Interstate Shellfish Sanitation Conference to address Vibrio vulnificus in the region, including discussing the scope of needed studies, and meeting with the Board in March 2010.

#2.       Working in conjunction with the National Marine Fisheries Service, the FDA will offer technical assistance to facilitate implementation of post-harvest processing or equally effective alternatives, including:
a.         Validation of processing parameters that can be applied to post-harvest processes to achieve non-detectable levels of Vibrio vulnificus, while also preserving acceptable taste and texture, and ensuring that this information is in the public domain so that all processors can use it.
b.         Studying alternatives to post-harvest processing, including off-shore relaying in which oysters are harvested and moved to salty waters where the high salinity kills Vibrio vulnificus.
c.         Providing technical assistance to firms in development of their post-harvest processing processes and HACCP plans.

#3.       The FDA will work with other federal agencies, such as the USDA and the National Oceanic and Atmospheric Administration in the Department of Commerce to review what types of grants and other forms of economic assistance may be available to support establishment of processing cooperatives or other mechanisms to ensure widespread access to post-harvest processing facilities.

#4.       As USTR and the oyster industry work to foster wider access to international markets that are now closed because of concerns about Vibrio vulnificus, FDA's new approach should provide public health and science data to support the safety of these products for human consumption in the US and abroad.