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Michael R. Taylor - ISSC Biennial Meeting

Remarks by

Michael R. Taylor
Senior Advisor to the Commissioner
Food and Drug Administration

ISSC Biennial Meeting
Manchester, N.H.

October 17, 2009

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.


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