These are the remarks by Michael R. Taylor, Senior Advisor to the Commissioner, Food and Drug Administration at the ISSC Biennial Meeting in Manchester, N.H., on Oct. 17
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Good afternoon. I thank you for giving me an opportunity to speak with you today about food safety.

I would like to talk about how the Food and Drug Administration sees its role in the nation’s food safety system, how we aspire to work in partnership with the states to build an integrated national food safety system, and steps we believe are necessary to address a matter of public health concern that I know is of particular interest to the members of this conference, namely Vibrio vulnificus in raw oysters.

First, however, I want to acknowledge the important role the ISSC plays in our food safety system. The ISSC has a long history of working collaboratively among the states and with FDA to improve shellfish safety. The ISSC’s members perform critical food safety tasks at the local level, where food safety begins, ensuring for example that the waters from which shellfish are taken are of appropriate quality and that processing plants maintain good basic sanitation. FDA values such efforts and considers them an important part of future efforts to improve food safety.

FDA’s role in the nation’s food safety system is exemplified by the seafood HACCP rule that the agency issued in 1995. This rule established the standards for modern preventive process control to ensure the safety of food moving in interstate commerce. It is a risk-based system that focuses on the hazards reasonably likely to occur in a seafood operation and requires the implementation of available control measures to “prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.”

Today, FDA is increasingly expected to be the source of national standards that help ensure appropriate, science-based controls are implemented to address significant hazards. For example, FDA has recently embarked on a process to develop rules to help ensure the safety of fresh produce.

We are very conscious of the fact that there is great diversity in the scale and type of operations in our agricultural and food systems. And we are committed to respecting that diversity in all that we do, ensuring that the measures we take are well-targeted to achieve legitimate public health purposes. But our job is to set at the national level standards that ensure the safety of food in interstate commerce by, as much as possible, preventing hazards from entering the food supply.

Setting standards, however, is not enough. To achieve our goal of protecting consumers from foodborne hazards, we must also ensure high rates of compliance with food safety standards. And in this we must increasingly rely on partnership with state health and agriculture departments, laboratories and environmental health specialists. The ISSC and the agencies that are members of the ISSC are good examples of partners on which FDA has long relied, and we want to continue our partnership well into the future.

In fact, the President’s Food Safety Working Group, which is co-chaired by the Secretary of Health and Human Services and the Secretary of Agriculture, called in July for building a truly integrated national food safety system. This will mean even broader collaboration with our state and local colleagues and greater investment in building state and local capacity to function as effective partners in an integrated national food safety system.

This brings me to the topic of Vibrio vulnificus in raw oysters. I am of course aware of the collaborative efforts we have made through the years to reduce the risk associated with this significant hazard, including disseminating educational messages and programs to encourage those at increased risk of illness from Vibrio vulnificus to eat their oysters cooked.

The at-risk population includes those with weakened immune systems or otherwise impaired health, including people with chronic diseases such as AIDS, cancer, kidney disease, diabetes, and alcohol abuse.

Reaching members of these high risk groups and persuading them to change their behavior with respect to shellfish consumption or other risk factors has proven extremely difficult, especially because many of the individuals are not even aware that they have a chronic disease. In fact, of the nearly 24 million people with diabetes, almost 6 million are not yet diagnosed. And another 57 million people have pre-diabetes. And when those with liver disease due to heavy drinking need to receive the message, education is that much harder.

It is thus not surprising that education aimed at behavior change has not achieved the 60% reduction in Vibrio cases to which the ISSC has aspired.

More recently, the ISSC has fostered efforts to achieve more effective refrigeration practices, including the refrigeration of oysters sooner after harvest than had been done previously. This may have resulted in some decline in cases of Vibrio infection, but the decline has been minimal.

Again, we recognize and commend the effort that went into both of these undertakings.

With the inability of these interventions to make significant gains, however, we face a real challenge. But rarely in public health are the data so incontrovertible. Between 2001 and 2008, in spite of the efforts many have made, there has not been a significant decline in the number of cases of Vibrio vulnificus nationwide.

Recent data from the Centers for Disease Control show that the goal of reducing the number of cases of Vibrio vulnificus in California, Florida, Louisiana, and Texas by 60% was not achieved.

Even under the most optimistic analysis, only a 35% decline in rates was reported in these states during this time, but much of this is attributable to the State of California’s decision to ban the sale of all Gulf Coast Oysters harvested during the summer that are not processed post harvest.

We know that this lack of progress is not acceptable to anyone. And so we believe that the time has come for a new approach.

As you know, with your support, industry, academia, and government have developed technologies that can largely eliminate the risk of Vibrio infection while preserving the sensory qualities of raw oysters. These Post Harvest Processing (PHP) technologies have been employed since the mid-1990’s. They include individual quick freezing (IQF) with frozen storage, high hydrostatic pressure, mild heat, and low dose gamma irradiation. And when they are used, the bacteria are killed and reduced to non-detectable levels. The risk is very substantially reduced.

In 2003, the State of California prohibited Gulf Coast oysters from entering the state unless they had undergone post-harvest processing. The results were stark. Between 1991 and 2001, 40 deaths had occurred in the State due to Vibrio vulnificus. Once PHP was required, the number of deaths dropped to zero, and has remained there for the last 6 years, with the only possible case during that entire period being investigated as we meet today. Post harvest processing -as required by California - has largely eliminated Vibrio vulnificus-related deaths and illness from consuming raw oysters.

Seldom is the evidence on a food safety problem and solution so unambiguous. The tools exist today to prevent people from becoming ill and dying from the Vibrio vulnificus bacterium. Oysters that undergo post harvest processing treatment will rarely pose a problem; while those left untreated can have deadly consequences.

And we understand that 15% of Gulf Coast oysters already are processed using these technologies, and that processing capacity in the Gulf Coast states is adequate to handle 100% of production.

With these facts in mind, we have examined the application of FDA’s seafood HACCP rule to the hazard posed by Vibrio vulnificus in raw molluscan shellfish and intend to reformulate our policy for addressing it. As noted earlier, our regulation requires that preventive measures for hazards that are reasonably likely to occur be sufficient to “prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.”

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.

The ISSC and FDA have collaborated to identify scientifically where and when the hazard is reasonably likely to occur - such as in the Gulf Coast in the warm weather months - but we welcome further dialogue on this point as we develop our formal guidance.

On this, however, we are clear: 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.

These considerations will inform our future implementation of the Seafood HACCP Regulation, with the intent that implementation of post-harvest processing or equivalent measures would be achieved for the control of V. vulnificus by the beginning of the risk season in 2011. When completed, this FDA policy change will be reflected in the “Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition,” which is currently under development at FDA.

I am providing this information to you today because we know it is relevant to your deliberations at this biennial ISSC meeting. I also wanted to be here personally to emphasize FDA’s commitment to further dialogue as we move forward on the reformulation and implementation of our policy.

As noted earlier, we are open to receiving new evidence and having further dialogue to clarify or refine where and when the hazard posed by Vibrio vulnificus is reasonably likely to occur. We also welcome evidence and dialogue with the ISSC and with industry members with respect to:

the availability of alternatives to post-harvest processing that are equally effective in reducing risk,
ways in which the impact of new control measures on small business can be mitigated - such as through technical assistance, organization of co-ops, or other ways to facilitate economically sustainable access to processing facilities, and
how the public can become aware of and value the safety enhancement gained through post-harvest processing.
We have not fully addressed the need, timing and manner of possible implementation of post-harvest processing for V. parahaemolyticus, which presents a significantly different risk profile and greater limits on the industry’s processing capacity. We invite dialogue with the ISSC and industry on these questions as well.

We are at a turning point in the quest for shellfish safety, but we are far from the end of the road. We at FDA seek dialogue with you as we navigate that road.

There is much work to be done to benefit consumers and, in the long run, the U.S. shellfish industry. We look forward to doing that work with you and with the ISSC.

Thank you again for including me in your meeting. I look forward to our discussion.

Backgrounder on Measures to Eliminate Risk Caused by Vibrio vulnificus Infection from Consumption of Raw Molluscan Shellfish

On October 17, 2009, FDA announced its intention to inform seafood producers of the need to take measures that will largely eliminate the risk of death and disease caused by Vibrio vulnificus (Vv) infection from consumption of raw molluscan shellfish (e.g., oysters and clams). The announcement was made at the biennial meeting of the Interstate Shellfish Sanitation Conference (ISSC) in Manchester, New Hampshire. The ISSC includes representatives of the shellfish industry as well as representatives of the FDA and other government agencies.

What is Vibrio vulnificus?
Vibrio vulnificus is a naturally occurring bacterium in the same family as those that cause cholera. Vv can be found in warm coastal waters, especially the Gulf of Mexico between the months of April and October. The level of Vv in Gulf of Mexico oysters greatly increases during warm weather months, resulting in the annual occurrence of illnesses in consumers who eat oysters raw. V. vulnificus can infect the bloodstream, causing a severe and life-threatening illness characterized by fever and chills, decreased blood pressure (septic shock), and blistering skin lesions. V. vulnificus bloodstream infections are fatal about 50% of the time. Generally, 15 deaths per year result from Vv infection associated with the consumption of raw Gulf Coast oysters. At greatest risk are individuals whose immune systems have been compromised or have certain health conditions, such as: chronic alcohol abuse; liver, stomach, or blood disorders; cancer; AIDS; diabetes; or kidney disease. Many of these individuals do not know that they are predisposed to V. vulnificus infection.

What has been done nationally to date to reduce the risk of Vv?
The FDA has worked with the Interstate Shellfish Sanitation Conference for more than a decade to monitor and reduce Vv contamination. In 2001 the Interstate Shellfish Sanitation Conference adopted a seven-year plan designed to reduce illness from Vibrio vulnificus infection by 60%. If this reduction could not be achieved through voluntary means, the states would mandate post-harvest processing of raw oysters by industry or other measures to reduce the risk of illness. Between 2001 and 2008, the FDA, the ISSC, and a number of State agencies undertook an extensive consumer education campaign about the risk of raw oyster consumption aimed primarily at at-risk individuals. Efforts were also made to foster voluntary adoption by the industry of technologies that eliminate this pathogen while preserving the sensory qualities of the raw product, called post-harvest processing (PHP).  Although consumer studies have demonstrated modest increases in consumer awareness of the Vv risk by the at-risk population, there is little to suggest that there has been a significant change in consumption behavior.

Recent CDC data show there has been essentially no change in the number of Vibrio vulnificus infections or deaths resulting from consumption of raw oysters in those states that permitted the sale of untreated Gulf Coast oysters during the warm months. These data clearly demonstrate that sustained education efforts and voluntary adoption of PHP have not had the intended public health results.

There is evidence that controls that were designed to reduce, but fall well short of eliminating, the risk of Vibrio illness such as implementation of a five-hour time from harvest to refrigeration also have not been effective. While such controls were in effect for most of the 2008 Vibrio risk season, there has not been a significant decline in the numbers of Vv illnesses reported in that year as compared to previous years. This could be the result of difficulties in enforcement of this type of control, natural year-to-year variability in illness numbers, or other factors.

What technologies exist to prevent Vv?
Post harvest processing (PHP) involves the use of technologies that virtually eliminate the Vibrio pathogens but retain the sensory qualities of raw product. These technologies, developed by industry, academia, and government (with support of the ISSC), include low temperature heat, individual quick freezing with frozen storage, high hydrostatic pressure, and low-dose gamma irradiation. All of these technologies have been validated to reduce extremely high levels of the pathogen to nondetectable levels. Based in part on research performed by FDA, the oyster industry began use of PHP to control the risk of Vv in the mid 1990s. PHP is economically feasible and is already being used on 15% of half-shell oyster production in the Gulf of Mexico region, but the costs and disruption to the industry to implement PHP technology will be greater, especially for some small producers, than those envisioned as a result of previous ISSC-endorsed strategies.

Is PHP required anywhere?
Yes. In 2003, the State of California required PHP for the high-risk Gulf Coast oysters during the summer months and since that time has experienced no Vibrio illnesses or deaths (an investigation is on-going that will likely link an illness in California this year to PHP oysters). Between 1991 and 2001, prior to PHP being required, it reported 40 Vibrio deaths.

In addition, many safety-conscious retailers, such as Legal Sea Foods and Costco, only sell Gulf Coast oysters that have been post-harvest processed.

In response to its audit of the U.S. system for the control of molluscan shellfish safety, the European Union (EU) insisted on assurance from FDA that Gulf Coast product would not be exported to the EU during the at-risk season unless the risk of Vv was mitigated by measures such as PHP.

What action is FDA intending that processors take now to reduce death and disease from Vv and Vp?
FDA believes that additional controls need to be put in place, particularly in light of the availability of demonstrably effective and feasible PHP methods, and the failure of other measures to achieve the purpose of the HACCP regulation. The Agency believes that application of PHP, or other equally effective controls, is the appropriate preventive measure under the regulation for the control of V. vulnificus in shellfish when the hazard is reasonably likely to occur. It does not believe measures that reduce, but fall well short of eliminating the hazard, such as improvements in refrigeration, are sufficient to meet the purpose of the regulation, especially given the availability of PHP technologies.

Therefore, the Agency intends to modify its guidance to the industry on the implementation of the Seafood HACCP Regulation, the “Fish and Fishery Products Hazards and Controls Guidance,” such that implementation of PHP or equivalent measures would be achieved for the control of V. vulnificus by the beginning of the risk season in 2011. These technologies can virtually eliminate this hazard while preserving the sensory qualities of raw product.

Implementation of FDA’s policy will substantially reduce and possibly eliminate these deaths and is justified as well by the fact that previous risk reduction measures tried over the last 7 years by the ISSC have failed.

What costs will this impose on the industry, and what will FDA do to help them?
The Agency recognizes that this action will have an economic impact on processors, particularly small ones. According to a re-analysis of data from a 2000 Research Triangle Institute study, it costs three to four cents per half-shell oyster to use high-hydrostatic or warm water pasteurization PHP measures and about thirteen cents per half-shell oyster for IQF frozen product. But these numbers don’t tell the whole story. Each of these processes offer its own set of trade-related benefits, including the ability to harvest oysters when they are in prime condition and market them when natural stocks are of lower quality; long-term frozen shelf-life; and elimination of the need for a skilled shucker in the case of shucked PHP product. The elimination of the need for a skilled shucker for product treated with hydrostatic pressure actually results in a cost savings, primarily to restaurants, per oyster over untreated shucked product.

FDA, with the assistance of other Federal Agencies, will provide technical assistance to small processors, either directly or through the ISSC, to facilitate their adoption of available post-harvest processing technologies. Further, as it has in the past, FDA will dedicate research resources to promising new technologies in an effort to further reduce costs to the industry.

What role will ISSC and the States play in the future?
FDA intends to continue to seek the advice and support of the ISSC in the control of Vv. It is FDA’s hope that the deliberations at the 2009 ISSC biennial meeting, which begins on 10/17/09, can focus on ISSC strategies for the mandatory implementation, within the ISSC framework, of PHP for the control of this pathogen when the hazard is reasonably likely to occur.

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FDA Proposes Raw Oyster Ban
10/23/09 - 08:11 AM

WMBB News Department

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The Food and Drug Administration is considering a plan to ban the sale of live, in the shell oysters, for as long as eight months of the year. The surprise announcement came Saturday, October 17th, at a meeting of Shellfish Regulators in Manchester, New Hampshire.

Oystermen from Apalachicola to New Orleans are upset. They say such a move would cost thousands of jobs and tens of millions of dollars.

FDA officials suggest frozen or pasturized oysters, but many business owners say it is not the same.  The FDA says there are an estimated 76 million cases of foodborne illnesses annually in people who eat raw oysters.

Kevin Bogos is the Executive Director of the Franklin County Oyster and Seafood Task Force. He says there is no such thing as zero risk in life and people have the right ot eat a simple natural food that humans have enjoyed for thousands of years.

Bogos is in New Hampshire for the FDA conference. He says if the propsal to ban raw oysters passes, it would take effect in 2011. He says it would be a disaster for Franklin County.  He says Congressman Allen Boyd has already written a letter asking the FDA to put off such a decision.