Currently browsing posts about: Oysters

The Center for Science in the Public Interest (CSPI) has sued the FDA for ignoring its 2012 petition to prevent illnesses and deaths caused by eating raw oysters from the Gulf of Mexico contaminated with toxic Vibrio vulnificus.

The lawsuit, filed jointly with Public Citizen, asks the FDA to set standards to make sure these bacteria are “nondetectable in oysters and other molluscan shellfish sold for raw consumption.”

The FDA is supposed to respond to the complaint by July 25.

This issue goes back a long way.  I wrote about it in 2011 in the context of a Government Accountability Office (GAO) report, Food Safety: FDA Needs to Reassess Its Approach to Reducing an Illness Caused by Eating Raw Oysters.

Vibrio vulnificus bacteria are considered “flesh-eating;” they kill half the 30 or so people who eat contaminated raw oysters.   Treating the raw oysters before allowing them to be sold kills the bacteria.  California requires this and nobody eating California oysters gets sick from Vibrio.  As I wrote in 2011:

In 2001, the oyster industry trade association, the Interstate Shellfish Sanitation Conference (ISSC), promised the FDA that this industry would substantially reduce Vibrio infections in oysters within seven years through a program of voluntary self-regulation and education aimed at high-risk groups. If this program failed to reduce the infection rate, the ISSC agreed that the FDA could require oysters to be treated after harvesting to kill pathogenic Vibrio.

So what happened?  Late in 2009, the FDA said it would issue rules, but backed off under pressure from the oyster industry and friendly state officials.

Despite years of warnings and promises that it obviously has no intention of meeting, the Gulf oyster industry has been able to stave off FDA regulations for 15 years at the cost of about 15 preventable deaths a year.

CSPI and Public Citizen are trying the legal route.  I hope it works.

The Government Accountability Office (GAO) recently released a tough report on the FDA’s dispute with the Gulf Coast shellfish harvesting industry about oyster safety: Food Safety: FDA Needs to Reassess Its Approach to Reducing an Illness Caused by Eating Raw Oysters.

To better ensure oyster safety, says GAO, FDA should work with the oyster industry to (in my paraphrase):

• Agree on a nationwide goal for reducing the number of illnesses caused by the consumption of Gulf Coast raw oysters
• Develop strategies to achieve that goal
• Recognize that consumer education and time-and-temperature controls have not worked
• Recognize that the capacity to use postharvest processing methods does not currently exist.

As I explain in my book, Safe Food: The Politics of Food Safety, the FDA for more than a decade has been trying to prevent deaths caused by Vibrio vulnificus bacteria that contaminate raw oysters grown in the Gulf of Mexico.

These “flesh-eating” bacteria proliferate in warm months and are especially deadly; they kill half of the thirty or so people who develop infections from it each year.

In 2001, the oyster industry trade association, the Interstate Shellfish Sanitation Conference (ISSC), promised the FDA that this industry would substantially reduce Vibrio infections in oysters within seven years through a program of voluntary self-regulation and education aimed at high-risk groups.

If this program failed to reduce the infection rate, the ISSC agreed that the FDA could require oysters to be treated after harvesting to kill pathogenic Vibrio.

Postharvest processing involves techniques such as quick freezing, frozen storage, high hydrostatic pressure, mild heat, or low dose gamma irradiation, any of which reduces Vibrio vulnificus to undectable levels.

By most reports, the effect of treatment on the taste and texture of oysters is slight (although raw oyster aficionados might argue otherwise).

The California actions are instructive: In 2003, California refused to allow Gulf Coast oysters from entering the state unless they had undergone postharvest processing.  The result?  Sales of oysters remained the same but oyster-related deaths dropped to zero!

In contrast, states that did not require postharvest processing experienced no change in the number of deaths, meaning that the ISSC program had failed.

Late in 2009, the FDA announced that it intended to issue rules requiring postharvest processing of Gulf Coast oysters in summer months.

But less than a month later, the FDA backed off.  Under protest from Gulf Coast oyster harvesters, state officials, and elected representatives, the FDA agreed to postpone the oyster-processing rules indefinitely.

As the GAO understates the matter,

FDA and the ISSC do not agree on a common V. vulnificus illness reduction goal….If FDA and the ISSC are not in agreement on the illness reduction goal and strategies to achieve it, it will be difficult for the Gulf Coast states to move forward to significantly reduce the number of consumption-related V. vulnificus illnesses.

The GAO report further explains:

the ISSC continues to include California’s results in its illness rate reduction calculation along with Florida, Louisiana, and Texas. Doing so overstates the effectiveness of consumer education and time and temperature controls….

My translation: Despite years of warnings and promises that it has no intention of meeting, the Gulf oyster industry has been able to stave off FDA regulations for ten years at the expense of about 15 preventable deaths a year.

This is yet another example of political pressures blocking the FDA from carrying out its mandated food safety responsibilities.

Let’s hope the GAO report induces Congress to push this industry to get its act in order and the FDA to issue those regulations.

On November 13, the FDA announced indefinite postponement of rules requiring raw oysters from the Gulf of Mexico to undergo postharvest processing to destroy their content of Vibrio vulnificus, a particularly nasty “flesh-eating” bacterium.  According to accounts in the New York Times and in industry newsletters,  the FDA caved under pressure from the oyster industry and members of Congress representing oyster-harvesting regions in the Gulf.

The FDA has been trying for years to get the oyster industry to clean up its act and use post-harvest technologies to sterilize oysters in order to prevent the 15 or so deaths they cause every year.  The technologies include quick freezing, frozen storage, high hydrostatic pressure, mild heat, and low dose gamma irradiation.  When used, the methods reduce bacteria to undectable levels and deaths from Vibrio vulnificus infections to zero.  As the FDA puts it, “seldom is the evidence on a food safety problem and solution so unambiguous.”

The FDA took action on October 16.  It wrote a letter to the industry announcing the new rules.  It would expect oyster producers to use the techniques, especially on oysters harvested in summer months when bacteria levels are higher.  It also issued a background paper on why the techniques are needed, a fact sheet on oyster hazards, and a Q and A on the new policy.

On October 17, FDA official Michael Taylor gave a speech to the oyster industry outlining the policy.

Oops.  The oyster industry did not take well to the idea and went into organized action.

Now, the proposed rules are history.  As the FDA explains:

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.

My interpretation: 15 or more preventable deaths a year, every year, from oyster Vibrio must not be enough to elicit industry responsibility or FDA action.  That the FDA was forced to back down so quickly is not reassuring about this administration’s commitment to food safety.  Make no mistake.  This is a major setback to developing a strong food safety system.

One of the ironies here is that the FDA’s approach to oyster safety mirrored the approach taken by the very same Michael Taylor when he worked for the USDA in the mid-1990s.  Then, the administration backed him up on requiring science-based food safety procedures for meat and poulty producers.  This time, it looks like the administration pulled the rug out from under him and forced the FDA to back down.

Note: Thanks to Mike Taylor, safety rules are in place for meat and poultry.  Unfortunately, the current USDA isn’t enforcing them.  I will have more to say on that point in tomorrow’s post.

Another note: Center for Science in the Public Interest, which has been pushing for oyster safety for years, has organized a protest campaign.  Sign up here.