FDA Statement on Vibrio Vulnificus in Raw Oysters

/PRNewswire/ -- 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:

1. 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.
2. 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.
3. 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 U.S. and abroad.

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FDA Warns Consumers Not to Eat Raw Oysters Harvested from the West Karako Bay Section of Growing Area 3 in Louisiana

Toxic Note: This is not a warning I'll have to heed as never in a bazillion years would you catch me letting one of these slimy buggers slither down my throat. If I were stranded on a desert island and that was it, I'd wait a few days to see if a fish wouldn't flop up onto the beach. I understand that there are those who love these critter, raw, stewed, fried or however else they might come. So to those who will be heading out to their favorite haunt to slurp a few, read on:

The U.S. Food and Drug Administration (FDA) is warning consumers not to eat raw oysters harvested from West Karako Bay, a section of Growing Area 3 in Louisiana. These oysters, harvested from Dec. 3 through Dec. 21, may be contaminated with norovirus.

Symptoms of norovirus infection include nausea, vomiting, diarrhea and stomach cramping. Affected individuals often experience low-grade fever, chills, headache, muscle aches, and a general sense of tiredness. Most people show symptoms within 48 hours of exposure to the virus, with the illness lasting one to two days. However, the illness can become serious for the very young, the elderly and people with weakened immune systems.

Consumers who ate raw oysters on or after Dec. 3 and experienced these symptoms are encouraged to contact their health care providers and local health departments. Consumers concerned about the origin of oysters they have recently purchased should contact the place of purchase to determine if the oysters were harvested from the identified area during the Dec. 3-21 period.

FDA has received reports of norovirus infection in seven individuals who ate raw oysters on Dec. 13 at a restaurant in Chattanooga, Tenn. The Tennessee Department of Health's test results from two of the ill patients were positive for norovirus. FDA confirmed the presence of norovirus in shell oysters harvested from the West Karako Bay section of Growing Area 3 and were served at the restaurant. Louisiana Department of Health and Hospitals closed the affected growing area on Dec. 21. FDA is working with the states involved to determine if any additional actions may be necessary to ensure public health protection.

The original shipper of the oysters is Prestige Oyster Company of Theriot, La. The company shipped the oysters to Bon Secour Fisheries in Bon Secour, Ala. Bon Secour Fisheries, in turn, shipped the oysters to the restaurant in Chattanooga. Considering the shelf-life of the product, it is possible that suspect oysters from the designated area are still available in other retail and food service settings.

Persons with weakened immune systems, including those affected by AIDS, and persons with chronic alcohol abuse, liver, stomach or blood disorders, cancer, diabetes or kidney disease should avoid raw oyster consumption altogether, regardless of where the oysters are harvested.
Cooking destroys the virus, eliminating the risk of illness for both healthy and immunocompromised individuals. FDA advises that it's always best to cook seafood thoroughly to minimize the risk of foodborne illness. Consumers can continue to enjoy oysters in many cooked preparations by following this advice:

At Restaurants and other Foodservice Establishments:

Order oysters fully cooked.

In the Shell:

Purchase oysters with the shells closed. Throw away any oysters with shells already opened.
To prepare oysters for eating, choose one of the following methods:
Boil oysters until the shells open. Once open, boil for an additional 3-5 minutes.
Steamer - add oysters to water that are already steaming and cook live oysters until the shells open; once open steam for another 4-9 minutes.

Use smaller pots to boil or steam oysters. Using larger pots, or cooking too many oysters at one time, may cause uneven heat distribution, which may cause the oysters in the middle to not get fully cooked.

Discard any oysters that do not open during cooking.
Shucked Oysters:

To prepare oysters for eating, choose one of the following methods:
Boil or simmer shucked oysters for at least 3 minutes or until the edges curl.
Fry at 375 degrees for at least 3 minutes.
Broil 3 inches from heat for 3 minutes.
Bake at 450 degrees for 10 minutes.