Center for Science in the Public Interest

Sues Food and Drug Administration

In May 2016 the Center for Science in the Public Interest (CSPI), sued the Food and Drug Administration (FDA) in federal court to force the agency to regulate Vibrio vulnificus in shellfish harvested in Gulf Coast waters and sold for raw consumption.

(For more info on the difference between Vibrio vulnificus (Vv) and Vibrio parahemolyticus (Vp) see our Vibrio Fact Sheet).

(You can read about the lawsuit in Food Safety News).

Following is ECSGA Executive Director Bob Rheault's take on the CSPI’s efforts to regulate raw shellfish consumption:

I view this lawsuit as particularly problematic because the CSPI is pushing for a “non-detect limit” for Vv.  Imposing such a zero-tolerance policy would force the shellfish industry to post-harvest-process (PHP) almost every oyster we harvest in summer.  (PHP refers to those approved processes that reduce bacterial counts by several logs. These processes include irradiation, high pressure processing, pasteurization and extreme cold freezing. Unfortunately PHP kills the oyster.)

Using today’s technology we can detect Vv in essentially all U.S. growing waters during the warmer months of the year.  Even in states like New Hampshire, which has never had a single reported case of Vv illness, scientists have observed Vv in their growing waters in summer for decades.

We don't yet know if there are benign strains of Vv that do not cause illness at all (like the vast majority of Vp strains), or if there are perhaps some environmental triggers that cause the bacteria to start making the disease-causing hemolysin proteins under certain conditions.

What we do know is this.  Even though the lawsuit suggests that our industry has done nothing to address the risk of illness, I maintain that we can be proud of the many steps we have taken:

  • Over the past decade we have worked aggressively to address the risk of illnesses from Vibrios.  We have adopted radical new harvest regulations, speeding the time to refrigeration from 10 hours to (in many states) one-to-two hours in an effort to limit post-harvest bacterial proliferation.  We have invested millions in new infrastructure such as ice machines, on-board refrigeration, reefer trucks, etc.
  • Dealers have adopted new critical control points in our HACCP regulations.
  • States have stepped up education efforts to ensure that every harvester and dealer knows the risks of Vibrios and understands the regulations we have in place to minimize that risk.
  • The FDA used to provide several million dollars in physician-education funding to help health-care professionals do a better job explaining to immuno-compromised individuals (patients with liver disease, severe diabetes, organ transplants and those taking immuno-suppressing drugs) that they should avoid eating any raw proteins - especially raw oysters in summer.  Unfortunately the FDA has pulled back these funds on the rationale that many of those who became ill were found to be aware of the risk and decided to keep eating raw oysters anyway.
  • In most cases we have turned the corner and the rate of illnesses per meal from Vibrios appears to be on the decline, despite many more consumers now enjoying oysters in summer than used to be the case, and a doubling of oyster consumption on the East Coast in just the past six years.

There is no question that many challenges associated with Vibrios remain.  We are still struggling to efficiently differentiate between benign and pathogenic strains.  Detection and measurement remain expensive and difficult.  Since Vibrios are naturally occurring pathogens (not associated with pollution) we have a hard time predicting where and when they will show up.  And we don't really know how many cells it takes to cause illnesses (though the FDA estimates that for Vp it may be 30,000 or more).

For some time now we have been working to understand the environmental conditions that allow Vibrios to proliferate so we can better predict when problems will occur, but the correlations developed to date are frustratingly inadequate.  While Vibrios are clearly associated with warmer waters, sometimes illnesses peak well before temperatures do, and we still see occasional illnesses in cooler months.

And despite all these challenges it remains maddeningly difficult to get funding to study Vibrios.  We need better, faster and cheaper detection tools.  We need more information to better inform our predictive models.  We need better information about which environmental conditions, culture practices and harvest practices influence the distribution of pathogenic Vibrios.  And we need effective and affordable post-harvest treatments (depuration or wet-storage) that leave us with live shellfish.

Remember that disease caused by Vibrio vulnificus is very rare, only about 60 reported cases a year, with more than half of those as a result of wound infections.  Most doctors will never see a single case in their entire careers.  Although it is only a seriously threatening disease for immuno-compromised individuals, it does have a 50-percent mortality rate in that small segment of the population.  With about 30 illnesses a year (and 15 deaths) stemming from seafood consumption, Vv remains a public health threat and a PR nightmare.

Despite all the improvements to our regulations and harvest practices, the number of annual illnesses remains stubbornly high.  Perhaps the best thing we could do is to convince the susceptible population to stop eating raw shellfish.  If they could be convinced to stick with cooked shellfish we could probably eliminate the problem entirely.  If the FDA is forced to mandate PHP treatment for our industry to address Vv, it will be the only case I am aware of where we regulate to address the concerns of a very small segment of the population.

Even though Salmonella kills hundreds of people each year, and the immuno-compromised population is again far more susceptible to severe complications from Salmonella than your healthy chicken consumer, efforts to eliminate Salmonella in U.S. chicken have been defeated.

But if you really want to have nightmares, contemplate a future where all shellfish have to be post-harvest processed, resulting in dead meat on a shell, a short shelf life and a product that is quite different from fresh raw shellfish (despite what some studies appear to suggest).  Imagine a raw bar that serves only dead oysters...

Not a great image is it?

So remember to keep em cold!  It is the one thing we know we can do to minimize risk.  And if we fail to keep illnesses under control we can expect to be plagued by a whole raft of expensive new regulations.