INTRODUCTION:

The Gulf Oyster Industry Council (GOIC), an association of oyster growers and processors, is firmly committed to providing the finest, most wholesome molluscan shellfish product available to the American public. In meeting this commitment, the GOIC membership endeavors to meet all requirements of the National Shellfish Sanitation Program (NSSP). The GOIC is also committed to working with the U.S. Food and Drug Administration (FDA), the Interstate Shellfish Sanitation Conference (ISSC), and the shellfish regulatory agencies in the Gulf States, to ensure that the NSSP is fully implemented and that manpower and resources necessary to support the program are available.

Vibrio vulnificus is a naturally-occurring, warm water bacteria that can cause illness and death in persons with diminished ability to resist bacterial and viral disease. The two most common sources of Vibrio vulnificus infection are wounds incurred before or during exposure to seawater or seafood drippings, and ingestion of shellfish that contain Vibrio vulnificus. In 1997 - 1999, for example, 85 (47%) of the 180 cases reported to the Centers for Disease Control and Prevention (CDC) where the source of the Vibrio vulnificus infection was known were the results of wound infection.

Persons at the greatest risk from Vibrio vulnificus infection are individuals with underlying medical conditions that caused impaired immune systems (diminished ability to resist disease). An estimated 12 to 30 million people are believed to have medical conditions that place them at increased risk for Vibrio vulnificus infection. Despite the large at-risk population, however, the available epidemiological evidence suggests that only a very tiny fraction of individuals with impaired immune systems contract Vibrio vulnificus illness. While many of the at-risk population are believed to eat raw shellfish (more than 50 million raw oyster servings are made annually to the general public), the Vibrio vulnificus molluscan shellfish-associated illnesses reported annually, on average, are about 30 illnesses and 16 deaths. In some years the number of Vibrio vulnificus illnesses associated with wounds is greater than the number of illnesses associated with eating molluscan shellfish.

While the illness or death of any oyster consumer is regrettable, the GOIC believes that aggressive targeted education of the at-risk consumer and market-driven provision of shellfish specially treated to reduce Vibrio vulnificus levels (post-harvest treated) are the best ways to manage Vibrio vulnificus risk. The GOIC is committed to the long-term implementation necessary to accomplish this end.

BACKGROUND:

The U.S. General Accounting Office (GAO) was requested to evaluate the FDA's approach to oversight of state and foreign shellfish safety programs and the ISSC's strategy for reducing illnesses and deaths associated with Vibrio vulnificus. For the purposes of this report, shellfish means oysters, clams, mussels, and scallops. Shellfish safety programs in six states (Florida, Louisiana, New Jersey, New York, Texas, and Washington) were used to conduct this review.

GAO FINDINGS:

The GAO findings can be summarized as follows:

· FDA does not use existing information, including shellfish production and illness data, to make risk-based decisions about which programs should receive the most oversight. As a result, FDA's resources are not being used efficiently to achieve the greatest level of shellfish safety.
· FDA's ability to fully assess relative risk and allocate its limited oversight resources is limited by weaknesses in the compliance and effectiveness information it gathers on states' and foreign countries' shellfish safety programs.
· FDA does not have objective, measurable data on the effectiveness of HACCP requirements and other efforts by the states and foreign countries to reduce the amount of bacteria in shellfish and associated illnesses.
· The ISSC's strategy to reduce Vibrio vulnificus-related illnesses and deaths has not been successful.

GOIC CRITICAL ANALYSIS

Consumer education is the key to effective Vibrio vulnificus risk management.

The GOIC believes that the consumption and sale of raw oysters is safe and must be maintained in the marketplace nationwide. Throughout the United States, raw oysters are immersed in culturally based traditions involving specialty foods, ranging from holiday traditions such as Thanksgiving and Christmas celebrations to special celebration meals when dining out to meeting with friends at an oyster bar for a night of conviviality. The cooperative effort of the industry, the states and the FDA in the NSSP has caused the U.S. to become a world leader in providing safe shellfish for human consumption.

For some individuals with impaired immune systems, however, raw oyster consumption can lead to serious illness. The underlying medical conditions which cause impaired immune systems include diabetes, alcohol-related liver disease, hemachromatosis, cancer, chronic kidney disease, and HIV/AIDS. These individuals have reduced ability to fight bacteria and viruses, and therefore are highly vulnerable to infection. Raw protein foods with high levels of naturally occurring bacteria (for example, raw beef, other raw meats, and raw oysters) can cause infections in these individuals. Vibrio vulnificus, a naturally-occurring bacteria that can become concentrated in oysters during warm weather months, can cause a serious illness known as septicemia which can be fatal to persons with impaired immune systems. About 30 cases of Vibrio vulnificus illness leading to about 16 deaths occur annually from eating raw oysters. The GOIC believes that this number of illnesses can be substantially lowered by sufficiently funding an education program that targets at-risk consumers. This program would teach individuals with impaired immune systems to avoid eating raw oysters, to select raw oysters that have been specially treated (post-harvest treated) to reduce Vibrio vulnificus levels, or to enjoy oysters cooked. Cooking destroys bacteria. Personal management of risk is the key to reducing the number of Vibrio vulnificus illnesses and deaths, not destroying the cultural and economic future of thousands of families that depend on farming, harvesting, and processing traditional raw Gulf oysters.

Personal management of risk is widely used in medical and public health practice and everyday life. For example, individuals with diabetes are expected to manage their sugar intake. Over time, the market has responded by offering a wide variety of sugar free and reduced sugar products. Restaurants and other eating establishments routinely offer diners the choice of sugar and one or more sugar alternatives. When someone with diabetes overindulges in sugar consumption leading to severe illness or death, we regret their personal choice to take this risk. The public does not cry out for the banning of sugar.

The GOIC believes that management of personal risk by an informed consumer is the appropriate approach for managing Vibrio vulnificus risk. The FDA estimates the population of potential oyster consumers at risk because of impaired immune systems at 12 to 30 million individuals. While more than 50 million servings of Gulf oysters are consumed annually nationwide, only about 30 cases of Vibrio vulnificus illness occur annually from that population. Because only a tiny fraction of the at-risk population is affected, the GOIC believes that it is inappropriate and unnecessary to mandate post-harvest treatment of oysters during warm weather months, to restrict the harvest or sale of raw oysters during warm weather months, or to take other measures which make raw oysters unavailable to the vast majority of consumers who eat them without harm. Educating the at-risk consumers in the proper way to manage their risk can accomplish this goal without depriving others of a gastronomic pleasure that they enjoy. When some of these at-risk consumers fail to choose wisely, it is regrettable, but it is not justification to remove the freedom to choose natural raw oysters from millions of Americans who enjoy raw oysters annually. Our challenge, we believe, is to see that individuals with impaired immune systems receive the information to make an informed decision.

The epidemiological record does not support the FDA estimate that molluscan shellfish cause over 100,000 illnesses annually.

"In 1995, FDA estimated that shellfish caused over 100,000 illnesses and cost the nation about $201.9 million annually." (Page 7, GAO Report)

The GOIC does not concur with the FDA estimate that the U.S. produced oyster, clams and mussels are associated with more than 100,000 illnesses annually (Table 1, page 7). While the GOIC realizes raw molluscan shellfish are a potentially hazardous food product, the epidemiological record does not support the FDA estimate. Examination of the CDC epidemiological record does not show the repetitive recurrence of continuous outbreaks annually which would be present if the FDA estimates are correct. For example, the total number of shellfish-associated illnesses (excluding Vibrio vulnificus) reported to the CDC in 1996 and 1997 was 1,279 cases from 23 outbreaks. (1997 is the most recent year for which data are available.) These 1,279 illnesses represent less than 0.6% of the more than 200,000 illnesses FDA estimated would occur in this time frame. While the FDA claims that many shellfish-associated illnesses are not reported because the symptoms are so mild that individuals do not seek medical help, the GOIC finds it difficult to believe that the number of cases is under reported by more than 99%. (CDC has no data on the level of non-reporting of shellfish-associated illnesses, and thus has not made any estimate of such illnesses.) The true incidence of bacterial and viral disease associated with shellfish is not known, and most of the illness (gastroenteritis) cause discomfort but are not debilitating (i.e., individuals continue to perform at work or in other daily activities). For these reasons, the GOIC believes that attributing more than 100,000 estimated cases at a cost of about $81.4 million is a gross over estimation of a potential however undocumented problem.

The GOIC also believes that the FDA estimate of more than 100,000 shellfish-associated illnesses annually causes unease among molluscan shellfish eaters, particularly when quoted in the popular press or cited in reports. Consumer unease has the potential to affect product use or cause product avoidance resulting in the loss of revenue to the industry and the economy. GOIC firmly believes that people have the right to know that there is a risk in eating raw molluscan shellfish just as there is with many other foods eaten raw. However, the GOIC also believes that until it can be demonstrated otherwise FDA should confine its reporting to actual numbers of illnesses, or rate of illness per unit population, or some other recognized index. The GOIC would also request that the GAO and other agencies or groups refrain from citing this FDA estimate of shellfish- associated illnesses until a rigorous risk assessment, based on good science and verified data that has been peer reviewed, has demonstrated its validity.

The increase in the average reported Vibrio vulnificus illnesses 1994-2000 over the 1989-1993 time period is the result of better illness reporting.

"The annual number of [Vibrio vulnificus] reported illnesses and deaths is somewhat higher at the end of this time period than at the beginning as shown in Figure 3, page 9 of the report. It is not known whether this increase is due to better reporting, greater shellfish consumption, or an actual increase in the rate of shellfish illnesses." (Page 9, GAO Report)

The GOIC firmly believes that the increase in reported Vibrio vulnificus cases is the direct result of better reporting. We do not believe that it is the result of an actual increase in the rate of shellfish-related illness. An increase in reported documented illnesses is the logical outcome of the increased emphasis on this pathogen and was predicted by both the GOIC and the ISSC.

There has been increased emphasis on educating both public health and medical professionals to recognize the symptoms of Vibrio vulnificus illness and the profile of the potential victim. This has been accomplished through training seminars, information dissemination in the public health and medical communities, and media use. For example, Louisiana has notices posted in its medical emergency rooms to alert doctors to Vibrio vulnificus symptoms, and has provided training in their recognition and appropriate treatment, because early recognition and treatment can save lives. The Florida Department of Health in conjunction with the National Laboratory Training Network hosted a two hour satellite teleconference to train laboratory, epidemiological and environmental health professionals about Vibrio vulnificus. A video of the conference continues to be available upon request at no charge. Efforts such as these have resulted in better detection of Vibrio vulnificus cases.

In recent years molluscan shellfish consumption has also increased. In 1999, oysters were one of the top ten seafoods consumed in the United States. Seafood Business, a monthly trade magazine, has reported a steady rise in the sale of raw oysters and the proliferation of establishments featuring oysters on the half-shell. Oyster production for the half-shell trade in the Gulf States has varied from a low of about 65.2 million half-shell servings to a high of about 78.4 million servings in the interval 1994 - 2000. A half-shell serving is six raw oysters on the half-shell. As GAO pointed out in its report (page19), between 1994 and 2000, an average 30 illnesses and 16 Vibrio vulnificus-related deaths were reported annually to FDA and remained relatively constant overall during this period. The average remained more or less constant despite expanding markets for raw oysters and increased production in some years. Although it is too early to be certain, the GOIC believes that part of the reason that this average has remained fairly constant, even in high production years, is that the public education program is beginning to show effects. The fact that more raw shellfish are being consumed, while the number of illnesses is not increasing, suggests that the education program may be reaching the consumers at risk resulting in risk avoidance.

FDA does not use existing information, including shellfish production and illness data, to make risk-based decisions about which programs should receive the most oversight. As a result, FDA's resources are not being used efficiently to achieve the greatest level of shellfish safety.

Several weaknesses exist in the way FDA oversees states' and foreign countries' efforts to ensure shellfish safety. First, FDA has not adopted a risk-based approach to overseeing states' and foreign countries' shellfish programs. Although risk-based approaches are generally recognized as the most effective method for targeting limited resources, FDA's oversight approach is based on essentially equal treatment of all participants in the shellfish safety program. (Page 12, GAO Report)

The GOIC concurs with the GAO finding that the FDA has not adopted a risk-based approach in its oversight of state and foreign country shellfish programs. We believe that the program could be improved, particularly the oversight of foreign shellfish safety programs, by such an approach. A risk-based approach would allow FDA to target limited resources in the most effective manner, resulting in better HACCP implementation and decreased emphasis on program minutiae. This improvement would also improve state programs by providing the states with greater flexibility to target the specific concerns and needs of each state's shellfish safety program, as opposed to federally driven concerns which may have little relevance to the state's program needs.

The importance of using a risk-based approach cannot be overstated with respect to import of foreign product. The GOIC, the Molluscan Shellfish Institute, the Pacific Coast Shellfish Growers Association, other industry groups, and state public health officials have long decried the fact that foreign product is not subjected to the rigid standards imposed on domestic molluscan shellfish producers.

We agree with the GAO finding that

"the level of food safety risk in a state's or foreign country's shellfish program principally depends on the size and type of the shellfish industry, the public's rate of consumption of shellfish, and the state's or foreign country's compliance with safety requirements, such as properly classifying growing waters. For example, the risk of shellfish-related illnesses is likely greater for a state or foreign country that contains a large number of firms selling raw oysters, and that does not fully comply with the NSSP safety requirements, than it would be for one that sells significantly fewer raw oysters and fully complies with the requirements. (Raw oyster consumption has been associated with the most serious shellfish-related illnesses.) Changes in the organization of a state's or foreign country's shellfish safety program, the officials implementing the program, or its funding can also affect a program's compliance with NSSP requirements, and, consequently, the level of food safety risk."

We support the GAO's finding that use of this type of information in determining where to target FDA resources could improve the program.

The GOIC believes that in prioritizing where to place its limited oversight resources the FDA should review the information about foreign product generated by FDA or state shellfish programs, and that this information should be given equal weight with information concerning state shellfish safety programs. For example, if product from a foreign country tested by state programs shows a pattern of misrepresentation (raw product labeled as cooked), improper labeling, or a substantial history of shellfish-associated illness in the country of origin, FDA oversight resources that may have been diverted to a lesser problem in a state shellfish safety program should be diverted to oversight of that foreign program. If FDA lacks the authority to take action against foreign product in these situations, we would recommend that their limited resources be used to augment the resources of the states that can address this problem before the FDA resources are diverted to less important state problems, or repetitive annual inspections. In these situations, the risk to the consumer from foreign product is greater than the risk from domestic product.

"FDA lacks electronic access to information on state compliance with some safety requirements…" (Page 13, GAO report)

The GOIC both agrees and disagrees with this statement. We acknowledge that most states do not have an electronic database for their processing plant inspections, and that the lack of such a database is an impediment to rapid identification of statewide or national trends in compliance. To the best of our knowledge, solicitation of this type of data has not historically been a focus of the shellfish safety program or any other food safety program.

The GOIC agrees that, when possible, useful trend information should be gathered. However, the GOIC is concerned that the transition to an electronic database could result in the diversion of the limited resources available to FDA and the states to the establishment and implementation of the database instead of correction of pressing shellfish safety program concerns. Historically, FDA has not provided resources to the states for implementing the National Shellfish Sanitation Program (NSSP). States have provided program resources based on the importance of the shellfish resource or shellfish product in their state. Several states are still struggling to get computers for staff. If FDA should establish an electronic database, failure to provide the resources on the part of the state could become a noncompliance item which has no direct public health consequences but consumes state program resources as the state struggles to get out of the noncompliance status. Furthermore, we are uncertain as to whether the information gained is worth another layer of bureaucracy, and the manpower and monetary costs.

If FDA elects to implement an electronic database system for the shellfish safety program, it is essential that funding be provided to the states to purchase the necessary equipment and software and to train staff in its use. Placing this requirement on the states without providing them with sufficient resources will impede, not enhance, the existing program.

HACCP requirements and other efforts by the states to reduce the amount of bacteria in shellfish and associated illnesses have been effective although the tools used to measure effectiveness could be improved.

'FDA…has no data on the effectiveness of state programs." (Page 13, GAO Report)

The GOIC believes that the effectiveness of the state programs can and has been shown in maintaining shellfish safety. The incidents of illnesses associated with molluscan shellfish produced in the United States is among the lowest in the world. Since its inception in 1925, the NSSP has been successful in markedly reducing the incidence of shellfish-associated illness and maintaining this very low illness incidence.

Traditionally state shellfish program effectiveness has been measured by compliance with program requirements. Compliance has been assumed to result in the desired outcome of illness reduction. GAO has not provided any information to challenge this assumption, and the recent epidemiological record does not suggest that molluscan shellfish-associated illnesses are increasing. We believe that the program has been effective, but that today's technology has not been used to its best advantage to maintain and measure effectiveness.

The effectiveness of HACCP requirements and other efforts by foreign countries to reduce the amount of bacteria in shellfish and associated illnesses is not readily demonstrable.

The GOIC is not convinced that the same level of effectiveness can be demonstrated for foreign imports as has been demonstrated for state programs. The information generated by the countries of origin and supplied to FDA, and FDA information generated through overseas inspection visits has not been clearly shown to be as detailed and well documented as that which exists in state shellfish safety programs. Foreign programs have not been subjected to the same frequency and intensity of review as state shellfish programs. For example, in one two-week period in Maryland, in five inspections, the Health Department found imported molluscan shellfish from countries with no FDA oversight. The shellfish consisted of 63 cases of raw product and 632 cases of shucked product including seafood combos that contained molluscan shellfish. Many of the products had no source indicated, no cooking statement, no shipper identification, or no HACCP plans, or the HACCP plans did not indicate hazards. In addition, some products were raw and labeled as cooked, some were decomposed, and some had been treated with chlorine baths of 25 to 50 parts per million (an illegal practice). Information such as this supports the GOIC and shellfish industry contention that foreign product does not receive the same oversight as domestic product.

The use of objective, measurable data to determine program success is not a readily achievable goal.

"…The FDA lacked objective, measurable data to determine whether its HACCP program is effectively reducing hazards…a guiding principle of the Government and Results Performance Act is the use of objective, measurable data to assess how well an organization is achieving its goals." (Page 15, GAO Report)

The GIOC supports the use of objective, measurable data to determine whether the HACCP program for molluscan shellfish is working. The GOIC questions, however, whether appropriate bacterial or viral indicators can be found. Because molluscan shellfish are primarily a crop involving many different species of clam, oyster, mussel, and scallop grown under widely varying environmental and climatic conditions, the source of shellfish associated illness may be either man-induced or naturally-occurring conditions (e.g. Gynodinium breve toxin). These issues have concerned the NSSP since its inception and are the reason for the use of surrogates such as cell counts in the water column to estimate public health risk. In addition, the current rate of incidence of shellfish-associated illness is so low and the illness causing agent so variable that the ability to measure overall rate reduction on a national level is questionable. Molluscan shellfish, particularly when alive, do not lend themselves as readily as domestic poultry and meat to the establishment of bacterial baselines.

The GOIC cautions that any indicators or other measures selected would have to accommodate these many variations. Nationwide indicators may not be appropriate; regional measures may be needed. Because these measures will be the yardsticks for determining compliance, we would want to see any proposed measures thoroughly documented, validated and subjected to review through the ISSC before implementation. The additional burden of HACCP compliance should not be placed on industry if its benefits cannot be demonstrated, nor should the industry be subjected to additional requirements based on inadequate measurement tools.

The GOIC is concerned that the FDA is no longer collecting molluscan shellfish-associated illness data. Until about 1994, the FDA collected data from the states and other sources concerning any illness believed to be associated with molluscan shellfish, regardless of whether the illnesses are required to be reported to CDC. The FDA maintained an on-going record which was useful to the states and industry as a gauge of success and helped to identify pathogens that needed better risk management or that were emerging as possible concerns. While this record was not amenable to sophisticated analysis, its availability was useful in gauging whether the incidence of shellfish-associated illnesses is rising, declining, or remaining about the same, and in helping to focus program attention on possible emerging diseases. The GOIC would recommend that the FDA re-establish this data collecting effort.

Initiatives to reduce Vibrio vulnificus illnesses have had limited success.

"Initiatives to reduce Vibrio vulnificus-related illnesses and deaths have not been effective…V. vulnificus-related illnesses and deaths have continued throughout the past decade despite the ISSC's efforts to reduce them…Past education efforts have not shown any demonstrable reductions in V. vulnificus-related illnesses. As a result, it is unlikely that education alone will significantly reduce illnesses by the year 2008." (Page 16, GAO report)

The GOIC strongly disagrees with this GAO finding that initiatives to reduce Vibrio vulnificus illness have not been effective. The success of the ISSC's Vibrio vulnificus education effort should be judged by its ability to reach the at-risk consumers of shellfish, not by measurable reduction in a small number of baseline illnesses. The ISSC goal recognized from its inception that total illness elimination was not possible.

The GOIC agrees with the GAO finding that the ISSC has been remiss in effectively evaluating the success of its Vibrio vulnificus public education programs. The GOIC, however, does not support the conclusion that because the success of the public education programs was not appropriately measured, the programs were ineffective. Consumer education through label and menu warnings, consumer advisories, and various other media messages is a recognized public health practice used extensively for other foods. The success of this approach has not been measured for many of these foods, yet the approach is believed to be successful. The GAO conclusion that the ISSC's Vibrio vulnificus education programs are not successful because success was not measured is invalid.

An estimated 12 to 30 million people are believed to have medical conditions that place them at increased risk for Vibrio vulnificus infection. Despite the large at-risk population, however, the available epidemiological evidence suggests that only a very small number of the persons with impaired immune systems contract Vibrio vulnificus illness (about 30 illnesses annually). Because the number of illnesses occurring annually in this population is so tiny, reduction in Vibrio vulnificus illness is difficult to demonstrate. There is no way to measure the illnesses actually prevented through public education. The true effectiveness of the Vibrio vulnificus public education program may not be demonstrable as a reduction in the number of illnesses. The growth in the population of persons with impaired immune systems caused by medical intervention and aging, and the growth in the raw oyster eating population may offset any reductions achieved to date through education.

As discussed above, oysters were one of the top ten seafoods consumed in the United States in 1999, a good production year in the Gulf States. Yet despite the increase in sales, there was no demonstrable increase in Vibrio vulnificus illnesses. Oyster production for the half-shell trade in the Gulf States in 1999 resulted in about 73.1 million half-shell servings. (A half-shell serving is six raw oysters on the half-shell.) There was no notable increase in Vibrio vulnificus illnesses in 1999 although an estimated 7.9 million more half-shell servings were sold in 1999 than in 1998. As GAO pointed out in its report (page 19), between 1994 and 2000, Vibrio vulnificus-related illnesses and deaths have remained relatively constant overall during this period. This average remained more or less constant despite expanding markets for raw oysters and increased production in some years. The GOIC believes that part of the reason that this average has remained fairly constant, even in high production years, is that the public education program is beginning to show effects, even though the Vibrio vulnificus program lacks adequate funding. The fact that more raw oysters are being consumed while the number of illnesses is not increasing suggests that the education program may be reaching those consumers at risk resulting in risk avoidance.

"Between 1994 and 2000, 30 illnesses and 16 V. vulnificus-related deaths were reported annually, on the average, to FDA…and have remained relatively constant overall during this period." (Page 19, GAO Report)

The GOIC agrees with this fact but not the GAO's interpretation that the available data do not show a reduction in the number or rate of Vibrio vulnificus-related illnesses. In reaching their conclusion, GAO considered three points:

· The number of illnesses remains relatively constant;
· Annual oyster production remained about the same or declined slightly; and
· The level of raw oyster consumption is unknown.

The GOIC believes that the GAO missed some important points. Although raw oyster production remained about the same, there is limited evidence to suggest that the sale of oysters for the half-shell market actually increased during the 1994 - 2000 time period. In addition, the median age of the U.S. population is steadily increasing, accompanied by a steady increase in the life expectancy of persons with chronic diseases, thus increasing the proportion of the population with heightened susceptibility to Vibrio vulnificus illness. The GOIC believes that this accelerating increase in individuals that have impaired immune systems over the 1994 - 2000 time interval could be responsible for the more or less constant rate in illness and could be off-setting the gains made to date through public education. While the GOIC cannot currently demonstrate that a public education-driven illness rate reduction is occurring, this explanation is as plausible as the GAO proffered explanation. The GOIC believes that the measurement of public education success by the ISSC over the next three years will substantiate its belief.

The ISSC's Proposed Strategy is Unlikely to Reduce V. vulnificus-Related Illnesses and Deaths in the Near Term. (Page 21, GAO Report)

The GOIC does not support this GAO finding which is based primarily on the ISSC's lack of documentation concerning the success of its public education efforts. The reason for GOIC's disagreement were discussed previously. Public education has historically been one of the most effective tools in promoting public health, but it takes time to acquire funding and to develop and implement an effective program. The GOIC believes that the ISSC's Vibrio vulnificus public education plan has matured and will begin to show demonstrable results in the next few years.

Vibrio vulnificus illness associated with oyster consumption is unique in that there appears to be a prerequisite for serious illness. The victim must have an underlying health condition such as diabetes, alcohol-related liver disease or HIV/AIDS that renders his immune system impaired and makes him susceptible to a potentially fatal infection known as septicemia. The degree to which an individual's immune system must be impaired to contract serious illness is unclear, and the infective Vibrio vulnificus dose is not known. There may not be an infective dose in the traditional sense of other bacterial illnesses because the dose may vary in relation to the particular circumstances of impairment caused by the underlying medical condition of each immuno-compromised person.

Because only a very tiny fraction of the individuals with impaired immune systems contract Vibrio vulnificus illness, the GOIC believes that educated choice by consumers is the long term solution to counter-acting this illness. The public in many different surveys about many different foods and other products has repeatedly indicated that it wants information about options and the freedom to make an informed choice. The public is given information and choice for large numbers of potentially harmful foods, for example, char-grilled and raw beef.

The overwhelming majority of raw oyster eaters are not at risk from Vibrio vulnificus. These individuals should have ready access to raw oyster product year round and should not be forced to accept only post-harvest treated product, or denied access to raw oysters. A good public education program allows this freedom of choice.

To augment the efforts of the ISSC, the GOIC also has a on-going effort to educate the food service industry and the public about Vibrio vulnificus-related illness. For example, in August 2000, the GOIC participated in the International Association for Food Protection Meeting in Atlanta, Georgia to encourage molecular detection techniques for Vibrio vulnificus. In August 2000, the GOIC also met with the Auburn Sea Grant and Mississippi-Alabama Sea Grant Consortium to discuss regional Sea Grant participation in the education of at-risk oyster eaters. Additional efforts have been made by the GOIC in 2001 to promote public awareness of the Vibrio vulnificus risk. The GOIC worked with the Louisiana Oyster Task Force (LOTF) in February 2001 to provide information to at-risk consumers on the LOTF website. Also in February, GOIC members provided information concerning oyster post-harvest treatment at the National Fisheries Institute Technology Innovation Conference in Orlando, Florida. In March 2001, the GOIC members demonstrated Vibrio vulnificus reduction through the use of low-acid marinades at the Louisiana Oyster Dealers and Growers Association Convention. In June 2001, GOIC members worked with the Texas Department of Agriculture to educate chefs and distribute information about Vibrio vulnificus at the Texas Restaurant Show.

Where the configuration of the molluscan shellfish harvest areas lend themselves to short transport times to the dock following harvest, Gulf States have maintained the action level 4, six hours to refrigeration requirement.

"A 1996 ISSC-commissioned evaluation of the refrigeration requirements found that the action level 4, 6 hour requirement reduced bacterial levels in shellfish subjected to it…Nonetheless, in 1997, the ISSC modified the temperature control requirement for action level four…increased the time from harvest to refrigeration from 6 hours to 10 hours when the water temperature is greater than 84 degrees Fahrenheit." (Page 17, GAO Report)

The GOIC acknowledges that the ISSC did change the level 4 mandatory time to refrigeration from 6 to 10 hours when the water temperature is greater than 84 degrees Fahrenheit. However, three of the five Gulf States (the states most frequently associated with Vibrio vulnificus illness) continue to require oysters to be refrigerated within six hours of harvest when water temperatures are greater than 84 degrees Fahrenheit. The state regulatory agencies in these states, working with the industry, determined that even though there was no direct evidence that this practice reduced Vibrio vulnificus illnesses, there was some benefit in the six hour requirement. The three Gulf States continue to enforce the more stringent requirement and the benefits of any reduction in Vibrio vulnificus levels in shellstock refrigerated within six hours of harvest continue to accrue.

"Two primary options offer the potential for reducing illnesses and deaths more quickly than the proposed ISSC strategy while still maintaining a market for raw oysters - more stringent refrigeration requirements…" (Page 24, GAO report)

The GOIC does not dispute the FDA finding that refrigeration retards the growth of Vibrio vulnificus in molluscan shellfish. It has been known for many years that refrigeration retards the growth of most bacteria. However, given that estimated consumption of raw oysters from the Gulf States is greater than 50 million servings per year resulting in about 30 cases of Vibrio vulnificus illness, the GOIC is not convinced that the cost of immediate cooling or refrigeration will realize measurable benefits. The reasons for this skepticism are:

· Only a very tiny fraction of the individuals with impaired immune systems become infected with Vibrio vulnificus (about 30 illness cases per year out of an estimated impaired population of 12 to 30 million people).
· The degree to which the individuals immune system must be impaired to contract Vibrio vulnificus illness is unclear.
· The Vibrio vulnificus infective dose is not known and may vary in relation to the particular circumstances of each person with an impaired immune system.
· Given the small number of Vibrio vulnificus cases that occur annually (about 30), the industry questions whether any reduction in illness will be derived from meeting the logistical challenges of the very costly introduction of immediate refrigeration on boats.

The GAO report suggests that Vibrio parahemolyticus could be used as a model for Vibrio vulnificus risk management. FDA has estimated that if oysters were iced or refrigerated on harvest boats, the probable number of Vibrio parahemolyticus illnesses annually would drop from 3,000 to about 240. The GOIC has several objections to this approach.

· The mode of infection of the two organisms is not similar. The pathogenic strains of Vibrio parahemolyticus cause noticeable symptoms in healthy adults.
· Vibrio parahemolyticus outbreaks usually involve many people (tens to hundreds). Vibrio vulnificus cases are generally isolated to single at-risk individuals.
· The number of Vibrio parahemolyticus cases is overestimated in the FDA risk assessment. Examination of the CDC epidemiological record does not show the repetitive record of annual outbreaks that would be present if the FDA estimates are correct. For example, the number of shellfish-associated Vibrio parahemolyticus illnesses reported by CDC was zero 1993 to 1996. In 1997, of the 19 shellfish-associated disease outbreaks (765 illnesses total) reported to the CDC, only two outbreaks involved Vibrio parahemolyticus. (1997 is the most recent year for which CDC summary data is available.) If the FDA estimate of 3,000 illnesses per year due to shellfish transmission of Vibrio parahemolyticus is accurate, the epidemiological record should show many outbreaks and cases of shellfish-associated Vibrio parahemolyticus annually, but it does not.

The GAO report leaves the impression that the molluscan shellfish industry has rejected immediate refrigeration or other cooling alternatives without investigation. This is incorrect. Industry members have experimented with many different ways of cooling oysters, both on harvest vessels and at dockside, but have not yet found readily implemented, cost-effective methods. The ISSC has also sponsored work on shellfish icing, cold water baths and other cooling methods which have the potential to reduce temperature but may also reduce the shelf life of the live shellfish product. Investigation continues at both the ISSC and the industry level.

Mandatory post harvest treatment of oyster shellstock is not necessary.

Two primary options offer the potential for reducing illnesses and deaths more quickly than the proposed ISSC strategy while still maintaining a market for raw oysters …phasing in mandated post-harvest treatment. (Page 24, GAO report)

Too much emphasis by FDA and GAO has been placed on post-harvest treatment as the solution to Vibrio vulnificus illness. The GOIC believes that it is both unnecessary and irresponsible to force the post-harvest treated product on the industry and the public at large. All post harvest treatments for Vibrio vulnificus in some way alter the raw product. The result may or may not appeal to the raw oyster consumer. The assumption that the post-harvest treated product can be substituted for raw oysters, particularly in the raw bar trade, without consumer reaction or at little or no cost or risk to the shellfish and restaurant industries is incorrect. An analogy is the Coca-Cola® experience several years ago when the manufacturer introduced the "new coke" that was resounding rejected by consumers who favored the "classic coke." The result was the loss of millions of dollars in revenue, the need for an expensive advertising campaign to restore consumer confidence in the product, and the continued offering of both the new coke and the classic coke for consumer choice.

Like Coca-Cola®, raw oysters are immersed in culturally based traditions involving specialty foods. There is no guarantee that consumers, and particularly the at-risk consumers, will embrace post-harvest treated oysters on a wide scale. It will take years of market development, advertising and public education with public acceptance as the final arbitrator of success.

Mandated post-harvest treatment of product is also unnecessary. The vast majority of raw oyster eaters are not at risk from Vibrio vulnificus illness and should not be forced to accept an altered product, or pay the extra cost for a post-harvest treated product. The educated at-risk consumer is equally likely to refrain from eating raw oysters, thereby achieving the objective of risk avoidance, as to choose a post-harvest treated product that does not meet his taste and texture expectations.

Post-harvest treatment is a technology that can be used to offer the consumer a choice. It has the potential to meet the needs of a sub-population of oyster eaters, that is, the consumer who has an impaired immune system and wants to continue to eat raw or raw-like oysters. Before it is widely accepted, however, post-harvest treated product will have to be introduced to the food industry at the wholesale level, retail level, and restaurant trade level as a raw oyster alternative that has appeal to their clientele. Food purveyors should have the option of offering the consumer a choice. If food purveyors find an advantage in the post-harvest treated products, or consumers express a preference, than over time, through market forces, post-harvest treated products may become the products of choice. Market evolution, not government mandate, should be the determining factor.

The GOIC is also concerned that mandated post-harvest treatment for Vibrio vulnificus is another attempt by the FDA to eliminate raw shellfish product. Throughout the history of the National Shellfish Sanitation Program, the FDA at various times has tried to coerce the industry and the states into depurating all raw product or offering only cooked product, justifying this action as lowering the risk of shellfish-associated illness. If post-harvest treatment is mandated for Vibrio vulnificus in the Gulf States, the next logical step is to mandate nationwide post-harvest treatment for Vibrio parahemolyticus, which affects healthy adults, or for Norwalk virus, which according to FDA estimates is responsible for more than 95% of all molluscan shellfish illness.

The GAO relies heavily on the March 2000 Research Triangle Institute report to substantiate its claim that post-harvest treatment is a readily available industry option. The GOIC believes that this report does not accurately portray the reality of implementing post-harvest treatment on a wide scale and has provided critique of this report on other occasions. Our concerns with this report can be summarized as follows:

· The report does not accurately characterize the industry.
· The assumptions used to determine the cost and benefits to the industry are based on very limited data which are not reflective of the greater industry.
· Cost comparisons are predicted from a very small data base.
· Consumer acceptance of post-harvest treated product is not adequately addressed.

Reliance on this report may lead FDA and GAO to erroneous conclusions concerning the feasibility and acceptance of post-harvest treatment.

Many of the molluscan shellfish producers are small, family-owned businesses that have been providing raw oysters on the half-shell to the American public for many generations. The GOIC is concerned that mandated post-harvest treatment will force many of these families out of business because they lack the resources to install and maintain post-harvest treatment. Requiring these small firms to face extinction if they are unable to bear the unnecessary burden of post-harvest treatment when they have provided the public with acceptable product through many generations would be reprehensible.

"In addition, some industry groups are concerned that mandating post-harvest treatment would eliminate the option for consumers to purchase raw, untreated oysters. While the production off raw, untreated oysters would not be eliminated throughout the United States if post-harvest treatment was required only in certain states during certain months of the year, consumers in those states required to treat oysters may find it more difficult or expensive to purchase untreated, raw oysters." (Page 26, GAO report)

The GAO report intimates, based on the Research Triangle Institute report, that post-harvest treatment is feasible on a seasonal basis, and would have no market effect beyond inconveniencing some consumers. The GOIC does not agree. In order to maintain a market, particularly the raw half-shell market, a molluscan shellfish producer must be able to meet a year-round demand for raw oysters, or face a reduced or lost market. The demand occurs from customers not only in the state where the producer is located, but also the producer's regional and national customers. When the shellfish producer cannot meet the demand, the customer turns to another supplier that can meet the need, and the shellfish producer has reduced or lost his market. This situation is further complicated when the raw oysters may be natural or post-harvest treated product. As discussed above, these products are not readily interchangeable.

Because of markedly reduced or lost sales at both the wholesale and retail levels (except in a few niche markets), Gulf shellfish producers will not survive without year-round simultaneous access to both the natural oyster and the post-harvest treated oyster half-shell markets. In addition, the cost of post-harvest treatment in many cases will only be affordable if the Gulf shellfish producer is able to continue to simultaneously produce and market both natural and post-harvest treated oysters. To continue to exist, the Gulf shellfish producer must be able to compete year-round in both markets. Under the FDA and GAO scenario of mandated post-harvest treatment, Gulf shellfish producers are being asked to sacrifice their traditional markets and wager their livelihood, and their families' and their employees' futures on a post-harvest treated raw or raw-like product whose market acceptance is unknown, and whose availability is unnecessary except for a specific sub-population of individuals with an impaired immune system.

To reiterate the points made earlier in this discussion, the vast majority of raw oyster eaters are not seriously affected by Vibrio vulnificus illness. Only an extremely small fraction of the individuals with impaired immune systems are seriously affected by Vibrio vulnificus. Therefore, there is no justifiable public health reason to mandate post-harvest treatment of all Gulf oysters for the half-shell market.

The consumer is the ultimate arbitrator of risk.

The GOIC does not want to convey the impression that it is insensitive to the suffering of Vibrio vulnificus victims and their families. We deeply regret the illnesses and deaths and are strongly committed to educating those at risk to avoid raw oyster consumption, just as they need to avoid other potentially hazardous foods, such as under-cooked or raw beef. These at-risk individuals can still enjoy oysters cooked in many different ways or one of the post-harvest treated products. Our challenge, we believe, is to see that these individuals receive the information to make an informed decision. When some of these individuals fail to choose wisely, it is regrettable, but it is not justification to remove the freedom to choose natural raw oysters from the millions of Americans who enjoy raw oysters annually. When consumers believe that oysters should be post-harvest treated to protect their health, they will make their preferences known loud and clear in the marketplace, resulting in the post-harvest treatment of many, if not all, raw oysters.