The FDA livened up the normally mundane discussion at the Interstate Shellfish Sanitation Conference (ISSC) held October 17 – 23, 2009 in Manchester, NH.  Just days before the Conference convened attendees were warned that the FDA was considering mandating Post Harvest Processing (PHP) on all shellfish any time there was a risk of infection from either Vibrio vulnificus (Vv) or Vibrio parahaemolyticus (Vp) (see attached letter).

When the opening General Assembly convened Deputy Commissioner Mike Taylor presented the attached letter and delivered a speech (http://www.fda.gov/NewsEvents/Speeches/ucm187012.htm) stating that the FDA no longer supports the Vibrio Control Plan that they had endorsed and helped develop through the ISSC that was intended to reduce the number of illnesses and deaths caused by Vibrio vulnificus associated with oysters harvested from the Gulf states.

Taylor stated that the FDA believes that PHP "technologies have been developed that can largely eliminate this hazard while preserving the sensory qualities of raw product." And that the FDA was no longer satisfied that the approaches being used were likely to achieve the target 60% reduction in illness (from 13 deaths a year 1989-2002) because the political climate had changed with the new administration.  What this effectively means is that during the months May through September that all of the oysters harvested from Gulf Coast states will have to be treated with either high pressure, freezing or irradiation before being admitted into interstate commerce commencing in the spring of 2011.

Many were relieved that Vibrio parahaemolyticus was not included in the dictate, but it was clear from the discussions that ensued that Vp was initially included in the mandate right up until a few days before the letter was delivered, leading many to believe that regulation of Vp by similarly mandated PHP is probably just a few years away and will affect oysters harvested throughout the United States.

In the contentious discussions that ensued, FDA admitted there was no economic analysis or impact considered in making this decision.  Several attendees at the conference speculated that the FDA, after taking a beating in Congressional hearings for failing to prevent outbreaks related to peanuts and spinach earlier this year, was looking for an easy victory and saw oysters as the low hanging fruit.  Industry groups have been scrambling to assimilate the news and try to strategize about how to try and deal with the FDA's edict.  Many industry members and representatives asked for the ISSC to hold a special meeting in 2010 to allow time to perform consumer acceptance studies and economic impact studies before the FDA passes its new "guidance" on Vv control.  Industry is largely in agreement on the need for solidarity and action to attempt to push back on this issue with their Congressional delegation as vigorously as possible for many reasons.

This change in direction by FDA circumvents decades of cooperative negotiations between the industry, state regulators and the FDA.  As Executive Director of the East Coast Shellfish Growers Association, Robert Rheault stated "Having shattered this cooperative agreement gives me little confidence that the FDA will continue to support our state Vp Control Plans, and I shudder to think of the impact such a requirement would have on the East and West Coast industries. Without fresh live oysters to serve for the summer months I doubt that the thousands of raw bar customers around the country would willingly substitute dead, processed oysters. I fear many of our best customers would not survive. Our costs would go up by 10 to 15 cents per oyster and our perceived value to the customer would be slashed. Thousands of growers, harvesters, shuckers and restaurant workers would be added to the welfare roles. But the FDA has clearly stated that they are comfortable ignoring any potential economic impacts to the Gulf industry, the raw bars, dealers and restaurants that depend on year-round fresh product."