FDA Blinks In Face-Off Over Gulf Coast Oysters

Did Politics Trump Public Health?

Mike Taylor gave a speech last month to a meeting of the Interstate Shellfish Sanitation Conference ("ISSC"). And when Mike Taylor talks, the food industry sits up and takes notice. This time, industry members didn't like what they heard.

Michael R. Taylor is Senior Advisor to FDA Commissioner Dr. Margaret Hamburg, and is the Commissioner's food safety "go-to" guy. On announcing his appointment, Dr. Hamburg expressed the belief that Taylor's "...expertise and leadership on food safety issues will help the agency to develop and implement the prevention based strategy we need to ensure the safety of the food we eat.”

Taylor used the occasion of the ISSC meeting to present a proposed change in FDA policy on the sale of raw oysters harvested from the Gulf Coast during the summer. FDA's new approach – to be implemented in time for the 2011 season – would ban the sale of those Gulf Coast oysters unless they were subjected to some form of post-harvest processing.

Why did FDA decide that this new policy was necessary? Because of a bacterium by the name of Vibrio vulnificus.

Vibrio vulnificus is a normal inhabitant of warm salt waters, such as those found along the Gulf Coast. First recognized as a pathogen in the 1970s, V. vulnificus can be found in raw oysters harvested from Gulf waters in the warm summer months. The microbe may produce nothing more serious than a typical case of gastroenteritis in otherwise healthy individuals. But in some cases, it infects the bloodstream – a situation that can often be fatal.

Raw oysters contaminated with V. vulnificus have caused several disease outbreaks. For example:

• Between 1981 and 1992, the microbe was blamed for 14 cases of gastroenteritis and 72 cases of septicemia (generalized infection of the blood stream) in Florida among people who reported having eaten raw oysters. Thirty-five of the 72 septicemia victims died.
• In 1996, three residents of Los Angeles developed septicemia and died after consuming raw oysters harvested from the Gulf Coast.
• In 1989, V. vulnificus was responsible for 14 cases of septicemia and 4 cases of gastroenteritis in the four states that border the Gulf of Mexico. Nine people died.

In 2003, California took action. The state banned the sale of oysters harvested during the summer months (April 1 through October 31) from Gulf Coast waters, "...unless the oysters are treated with a scientifically validated process to reduce V. vulnificus to non-detectable levels." According to Mike Taylor, the California ban "...has largely eliminated Vibrio vulnificus-related deaths and illness from consuming raw oysters..." in that state.

Taylor added the following reasons for FDA's change of direction:

"We now believe that, under our HACCP rules, when raw oysters are harvested in waters and at times where V. vulnificus is reasonably likely to occur, the appropriate preventive measure is one of the available, validated post-harvest processing methods, or another control measure that can be validated to be equally effective. We base this belief on the availability of demonstrably effective post-harvest processing methods and the failure of other measures to achieve the purpose of the HACCP regulation."

"On this, however, we are clear," he went on to say, "We no longer believe that measures which reduce the hazard, but fall well short of eliminating it, such as improvements in refrigeration, are sufficient to meet the purpose of the regulation, given the severity of the hazard and the availability of post-harvest processing technologies."

FDA has been working with Gulf Coast states and ISSC for more than a decade on the V. vulnificus problem. ISSC adopted a seven-year plan in 2001 to reduce the incidence of infections caused by this bacterium by 60% through voluntary means. It was made clear back then that if voluntary actions failed, mandatory post-harvest processing of raw oysters would be imposed on the shellfish industry.

According to FDA, voluntary measures have failed. Nevertheless, Mike Taylor's October 17th announcement of FDA's new action plan resulted in a firestorm of opposition – both from industry and from the Gulf Coast states. Louisiana, especially, has led the opposition to FDA's proposal.

Last Friday, FDA backed down, saying 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..." before mandating post-harvest processing of raw oysters.

Already, without post-harvest processing, summer-harvested Gulf Coast oysters cannot be sold in California. They cannot be exported to European Union countries. They cannot be sold to certain retail chains, such as Costco.

ISSC and the Gulf Coast states have known since 2001 that mandatory post-harvest processing might become a reality. Their apparent shock and dismay is hard to understand.

Even harder to understand is FDA's willingness to shelve its planned policy change. Either Vibrio vulnificus is a danger serious enough to require action, or it is not. If it's not a significant hazard to the population, FDA had no business mandating post-harvest processing in the first place. On the other hand, if Vibrio vulnificus is a severe hazard – as Mike Taylor described it – FDA had no business backing away from its decision.

If this is the kind of performance that we can expect from Dr. Hamburg and FDA, Congress may just as well shelve that food safety regulatory reform its been working on. Good intentions and fine words on paper mean nothing without the will to enforce them.