Center for Science in the Public Interest

I. Executive Summary
II. Introduction
III. The FDA Plays Politics With Public Health
IV. The FDA is Charged With Protecting Consumers Against Unsafe Foods
V. The FDA Should Establish Standards Through A Fair And Impartial Process
VI. The ISSC Process Is Anything But Fair And Impartial
VII. The Shellfish Industry Has "Captured" The ISSC Process
VIII. How The FDA And ISSC Failed To Protect Consumers
IX. Timeline
X. Conclusions And Recommendations
XI. Endnotes


ISSC Activities

The Late 1980s to Early 1990s: Consumer Education Fails

Starting in the late 1980s-when the first regulatory proposals to control Vibrio vulnificus were considered-the ISSC has repeatedly responded by calling for more research and "consumer education" regarding shellfish safety, rather than harvesting bans during warmer months.(94)

The ISSC’s commitment to fixing Vibrio vulnificus was first directly tested at the 1990 annual meeting. There, a California public-health official urged the ISSC and FDA to take more aggressive measures, including a possible ban on the sale of Gulf Coast shellfish, because attempts to educate consumers, health-care providers, and others about the pathogen had been ineffective.(95) Not surprisingly, the ISSC Executive Board soundly rejected California’s proposal and instead decided to "continue the course of emphasizing education of at-risk groups rather than encourage action which inappropriately and adversely affected the shellfish industry."(96)

1989 V. vulnificus cases

2 deaths, 8 illnesses

1990 V. vulnificus cases

4 deaths, 5 illnesses

1991 V. vulnificus cases

3 deaths, 6 illnesses

1992 V. vulnificus cases

10 deaths, 10 illnesses

1993 V. vulnificus cases

9 deaths, 5 illnesses

1994: The FDA’s Call for Post-Harvest Controls Is Rejected

In 1994, the FDA conducted a two-day workshop discussing measures to more effectively control Vibrio vulnificus.(97) As a result of the workshop, the FDA concluded that "[m]uch skepticism remains that product labeling or [consumer] advisories alone will be sufficient to reduce illness and death to an acceptable level. . . . [and] immediate action is warranted."(98) The FDA developed a policy document outlining various methods to control Vibrio vulnificus, noting that the most effective post-harvest control available at that time would be to divert Gulf Coast oysters harvested during warmer months away from the raw market

(so-called "Option 2").(99) Thus, under Option 2, consumers of raw oysters would not eat the oysters most likely to be contaminated with Vibrio vulnificus, and the Gulf Coast shellfish industry could still make money by selling the "warmer harvest" oysters for cooking. The FDA strongly recommended that the ISSC adopt Option 2 at the 1994 meeting.(100)

The Gulf Coast shellfish industry was incensed by the FDA’s Option 2 proposal and brought overwhelming congressional pressure to bear on the state regulators who would be voting on the proposal at the ISSC. Senators Trent Lott (R-MS), John Breaux (D-LA), Thad Cochran (R-MS), and J. Bennett Johnston (D-LA), together with Representatives Robert Livingston (R-LA), W.J. "Billy" Tauzin (D-LA)(101), Earl Hutto (D-FL), Greg Laughlin (D-TX), Solomon Ortiz (D-TX), William Jefferson (D-LA), Douglas "Pete" Peterson (D-FL), and Sonny Callahan (R-LA), wrote a letter to the ISSC opposing Option 2.(102) Not surprisingly, at the 1994 ISSC annual meeting, state regulators rejected the FDA’s proposal by a 15½ to 11½ vote, sending the issue to a committee for further consideration.(103)

The ISSC’s vote did not necessarily spell the end of Option 2, because of the FDA’s nonconcurrence power. Some even believed that the FDA had made a "veiled threat"(104) that it would act independently if the ISSC did not adopt Option 2. However, FDA Commissioner David Kessler had been summoned to Capitol Hill by Senators John Breaux (D-LA) and J. Bennett Johnston (D-LA), and Representatives Robert Livingston (R-LA), W.J. "Billy" Tauzin (D-LA),(105) James Hayes (D-LA), and William Jefferson (D-LA), even before the 1994 ISSC meeting.(106) Notably, Senator Johnston and Representative Livingston served on the Senate and House Appropriations Committees, which control the funding for FDA and other government agencies. When put to the test by the ISSC vote, the FDA refused to impose Option 2 as a federal mandate.(107)

1994 V. vulnificus cases

11 deaths, 13 illnesses

1995: The FDA Abandons Option 2

Over the next several months, the ISSC’s Consumer Protection Committee developed a much weaker alternative to the Option 2 marketing restrictions. Instead of diverting oysters to the cooked product market, the committee wanted to prevent growth of Vibrio vulnificus by restricting the length of time that the shellfish could remain unrefrigerated after harvest to 14 hours during hot months.(108) The FDA severely criticized the committee’s proposal, because the agency’s data showed that Vibrio vulnificus in shellfish left unrefrigerated after harvest can increase 10-fold in 3.5 hours and 100-fold in 14 hours, but "immediate refrigeration" can maintain "at harvest" levels of the bacterium.(109) FDA officials took the position that shellfish should remain unrefrigerated for no more than two hours after harvest during warmer months.(110) Moreover, the FDA continued to support the post-harvest marketing controls in Option 2 as the best means to protect consumers from Vibrio vulnificus-contaminated raw shellfish.(111)

With negotiations dragging on, FDA Commissioner Kessler was called to yet another meeting with Senator John Breaux (D-LA) and the Gulf Coast Oyster Commission he chaired, to defend the FDA’s position.(112) Although Commissioner Kessler refused to comment after the meeting, others who were present implied that Kessler caved in: "[H]e suggested it might be better to go with the ISSC alternatives instead of a suspension during warm months [as some FDA officials had recommended]. . ."(113) The Louisiana oyster industry also flooded the offices of its congressional delegation with letters asking for education and not a ban.(114) The Louisiana Members were in an excellent position to communicate with the FDA, because Representative Bob Livingston (R-LA) was then the chair of the House Appropriations Committee. As the FDA and ISSC hammered out a compromise plan, discussion of Option 2 effectively ceased.

The Vibrio vulnificus control plan adopted at the 1995 annual meeting bore all the hallmarks of a heavily negotiated compromise. Previously, the FDA had insisted that shellfish had to be refrigerated within two hours after harvest during warmer months-otherwise, the bacteria would reach dangerous levels.(115) At the ISSC, the FDA accepted a plan (a "time-temperature matrix") that allowed Gulf Coast shellfish to sit on board harvesting vessels for up to six hours after harvest during the hottest months, despite FDA data showing that Vibrio vulnificus could multiply more than 10-fold during that time period. In short, the ISSC and FDA developed a plan grounded on what the Gulf Coast industry was willing to accept, rather than on what scientific studies had shown would best protect the consuming public.(116) That was not the last time that the FDA would fold under industry pressure.

1995 V. vulnificus cases

14 deaths, 18 illnesses

1996 V. vulnificus cases

23 deaths, 10 illnesses

1997: The FDA Accepts An Even Weaker Industry Plan

The FDA’s actions became even more indefensible when, in 1997, following one of the worst years ever for reported deaths and illnesses from Vibrio vulnificus, the FDA backed a proposal to increase-not decrease-the maximum amount of time shellfish may remain unrefrigerated during the warmest months. Instead of the six hours permitted under the 1995 time-temperature matrix, the FDA supported an amendment giving harvesters up to 10 hours to refrigerate their catch-the same length of time that the FDA had rejected previously as insufficient to protect public health.(117)

The FDA’s stated rationale for further weakening an already feeble plan was that the time/temperature controls appeared not to be working; therefore, the industry should be relieved from the "economically burdensome requirement."(118) Once again the agency ignored its own scientific data regarding the growth rate of Vibrio vulnificus at high temperatures and failed to acknowledge that the time/temperature controls might not have worked because the six-hour maximum had been too long in the first place. Instead of following the science-by reducing the time limit to two hours (as the agency originally had proposed) or by reviving Option 2-the FDA followed the industry’s lead and further relaxed the refrigeration requirements. True to form, the ISSC and FDA once again allowed economics to trump public health.

1997 V. vulnificus cases

10 deaths, 10 illnesses

1998-1999: ISSC Opposes Post-Harvest Treatments to Kill Vibrio vulnificus

The ISSC has been unwilling to embrace new technologies to clean up shellfish. The first proposal for mandatory post-harvest treatment of shellfish was submitted to the ISSC in June 1998 by the developer of the mild-heat pasteurization technology, AmeriPure Oyster Companies.(119) AmeriPure’s proposal got an unenthusiastic reception at the ISSC-it was referred to the committee for another year.(120)

At the 1999 ISSC annual meeting, the same committee passed a resolution that, in effect, opposed the use of any post-harvest treatment to reduce levels of Vibrio vulnificus in Gulf Coast shellfish.(121) Eventually, the committee withdrew that resolution, but only after a National Oceanic and Atmospheric Administration representative expressed his concern that this resolution would be sending the wrong message and a high-ranking FDA official concurred. A substitute resolution was passed declaring the Conference’s commitment to encouraging the development and approval of post-harvest-treatment processes.(122) But it was unmistakably clear that the ability of scientists to develop new ways to kill the deadly pathogen in shellfish had already far outstripped the ISSC’s willingness to require processors to use those technologies.

1998 V. vulnificus cases

18 deaths, 14 illnesses

1999 V. vulnificus cases

18 deaths, 14 illnesses

2000: ISSC Rejects Its Own Vibrio vulnificus Control Plan

Perhaps sensing just how badly consumers perceived its past behavior, near the end of the 1999 meeting, the ISSC launched yet another committee, the Vibrio Management Committee (VMC), to oversee and evaluate the implementation of the ISSC’s risk-management strategies for Vibrio species.(123) The ISSC pressured the FDA to conduct its efforts relating to the Vibrio species "in conjunction" with the committee, a move clearly designed-at least in part-to maintain the ISSC’s control over the Vibrio vulnificus issue and to discourage the FDA from taking independent action.(124)

2000 V. vulnificus cases

16 deaths, 12 illnesses

Known Deaths & Illnesses

263 TOTAL KNOWN V. vulnificus CASES (1989-2000)


Over the following year, the VMC developed a new Vibrio vulnificus risk-management plan. The plan would have applied to states whose shellfish, including oysters and clams, had been linked to two or more Vibrio vulnificus illnesses. The goals of the risk-management plan were to reduce the rate of shellfish-borne Vibrio vulnificus illnesses by 40 percent by 2005 and 60 percent by 2007. If the 60-percent illness-reduction goal was not met by the end of 2007, the affected states would be required, during warmer months, to label all shellfish as unfit for raw consumption, close shellfish growing areas for shellfish harvesting, or treat all shellfish intended for raw consumption to kill the Vibrio vulnificus.(125)

The risk-management plan also included a Vibrio vulnificus management guide, outlining how progress toward the 40 percent and 60 percent illness-reduction goal would be measured. The guide also encouraged implementation of post-harvest treatment methods by setting a goal to treat, by 2003, 20 percent of the Gulf Coast oysters harvested during the months of May to September and intended for the raw market.

The VMC’s proposed risk-management plan (and guide) was modest at best-it would have given the shellfish industry another five to seven years to reduce deaths and illnesses before any new labeling or harvesting restrictions or post-harvest treatment requirements would have kicked in.(126) Until then, states were allowed to continue their campaigns to educate consumers about the risks of consuming raw shellfish or use other means the state believed would help to prevent shellfish-related Vibrio vulnificus infections.(127) Amazingly, if the proposed harvesting-bed closure or labeling requirements were put in place in 2008 (the earliest possible time under the VMC plan), the ISSC would have taken 18 years to implement requirements first proposed in 1990.

Once again, Gulf Coast lawmakers played an active role in the ISSC process. Representative Nick Lampson (D-TX) gave a keynote address at the 2000 ISSC meeting; Representative F. Allan Boyd (D-FL) sent a staffer to speak on his behalf; and Senator Bob Graham (D-FL) wrote a letter voicing his support for the industry. All three Members opposed the Vibrio vulnificus risk-management plan.(128)

The 2000 ISSC meeting was a defining moment in the Conference’s history.(129) Throughout the meeting, voting participants were repeatedly reminded by top-level ISSC officials that the ISSC’s credibility would be seriously damaged if it again failed to take decisive action against Vibrio vulnificus.(130) Despite those exhortations, the Gulf Coast industry and sympathetic state regulators wasted little time in embarking on a campaign to weaken the VMC’s modest risk-management plan. For instance, a Gulf Coast industry representative introduced a successful amendment that excluded all shellfish other than oysters from the plan. The FDA readily concurred in that effort, even though an FDA epidemiologist was present who was fully aware of the seven reported deaths and six illnesses since 1989 linked to raw clams.(131)

The Gulf Coast industry also undermined the risk-management plan’s Vibrio vulnificus illness-reduction goals. Instead of allowing the CDC to establish estimates for underreporting of Vibrio vulnificus illnesses, the Gulf Coast industry proposed-and the task force adopted-a provision allowing ISSC members themselves to develop the estimates.(132) (Estimating the impact of foodborne diseases is complicated, because many people who suffer less severe types of foodborne illness may not seek medical care and, in the case of more serious illnesses such as Vibrio vulnificus infections, may be misdiagnosed. In 1999, the CDC projected that the total number of foodborne Vibrio vulnificus cases to be twice the number of reported cases.(133)) One prominent member of the Gulf Coast shellfish industry stated: "Maybe we can change this back to [the] CDC once we establish a relationship of trust with them."(134)

Before the modified risk-management plan (including the guide) was put to a final vote, many ISSC and federal officials pleaded with the delegates to approve the amended plan without further delay. But the Gulf Coast oyster industry remained steadfastly opposed to the proposal. A Gulf Coast industry representative told the voting delegates that the risk-management plan’s "direction is wrong because the emphasis is on post-harvest treatment."(135) Unfortunately, by a margin of 13½ to 13, the voting delegates once again sided with industry and sent the plan back to the VMC for further review.(136) With that vote, the ISSC sent its latest, unambiguous signal that it is unwilling to take even the most modest of steps to address a problem that kills or sickens several dozen people each year.
After the vote, even longstanding supporters of the ISSC voiced disgust. Nancy Ridley of the Massachusetts Department of Health, a long-time ISSC participant, said that the ISSC’s inaction "raises serious questions as to the ability of the conference to take on tough challenges."(137) Ridley stated: "I am hoping that there is a future for the conference. The action they took affects the credibility of that process."(138)

To those who have waited in vain for over a decade for the ISSC to take meaningful action regarding Vibrio vulnificus, the events of 2000 come as no surprise. But the significance of the Conference’s rejection of the risk-management plan should not be lost. By succumbing to industry pressure and voting down a modest plan that enjoyed the overwhelming support of the federal government and many state regulators, the ISSC has shown- beyond any shadow of a doubt-that it is incapable of acting in the best interests of consumers of raw molluscan shellfish. It is time for the FDA and other federal agencies, as well as responsible state regulators, to recognize that fact and take independent action on the Vibrio vulnificus issue.


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