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  Letter to Dr. Jane Henney

May 10, 2000
Dr. Jane Henney, Commissioner
Food and Drug Administration
5600 Fisher Lane
Rockville, MD 20857

Dear Commissioner Henney:

     The summer is almost upon us, and with it this year’s deadly oyster harvest. Over the past decade, raw shellfish contaminated with Vibrio vulnificus have killed or sickened an average of 22 people each year. Those who develop primary septicemia following exposure to Vibrio vulnificus face a cruel fate: over 50% die from the infection, and survivors can suffer lifelong debilitating injuries. On behalf of the Center for Science in the Public Interest (CSPI) and fellow Safe Food Coalition members Consumer Federation of America, Public Citizen, and Safe Tables Our Priority, we write to urge you to take the steps necessary to put an end to the needless tragedy caused by Vibrio vulnificus-contaminated raw shellfish.

     On June 29, 1998, CSPI submitted a citizen petition, Docket No. 99P-0504, asking the Food and Drug Administration (FDA) to require a performance standard of nondetectable levels for Vibrio vulnificus in molluscan shellfish intended for raw consumption. We explained that shellfish processors could eliminate the deadly bacterium from their products by using readily available post-harvest treatment technologies, and that adoption of the performance standard would spur the development of new, cost-effective treatments that could better protect consumers from contaminated shellfish.

     FDA has not yet responded to CSPI’s petition, though the agency sought public comments on our request in a January 21, 1999, Federal Register notice. The comment period for that notice closed over one year ago. As Commissioner of the agency charged with ensuring seafood safety, you have a responsibility to act now to protect the public from Vibrio vulnificus-contaminated raw shellfish by taking the action urged by CSPI.

     The Research Triangle Institute (RTI) recently completed a report on how CSPI’s proposed performance standard would affect the oyster industry.1 The report provides strong and unambiguous support for the regulatory change urged by CSPI. It confirms that the costs to the industry of treating its oysters to destroy Vibrio vulnificus are minuscule in comparison to the economic benefits that would result from the elimination of deaths and illnesses caused by contaminated raw oysters.

     According to FDA’s own estimates, those deaths and illnesses cost the U.S. approximately $120 million per year.2 The RTI study shows that industry-wide adoption of post-harvest treatment technologies would cost the industry approximately $14 million — though adoption of one of the available technologies would actually save the industry approximately $2 million annually.3 This means that the economic benefits of the requested standard would be at least eight times greater than its economic costs to the industry, even if the industry could not pass those costs on to its customers. And this analysis does not take into account the tremendous non-economic benefits the performance standard would yield, including ending the emotional suffering by victims and their loved ones. Even the staunchest critic of government regulation would be forced to concede that this case presents an economic “no-brainer.”4

     Any further delay in imposing the requested performance standard is inexcusable. FDA will neglect its public-health mission if, instead of taking immediate action, it continues to rely upon the Interstate Shellfish Sanitation Conference (ISSC) to address the Vibrio vulnificus problem. The ISSC has been meeting on Vibrio vulnificus since the early 1990s, with few (if any) positive public-health results. Labeling, where adopted, has had only a limited effect. And the ISSC’s weak time/temperature controls for raw shellfish have been a dismal failure. In 1998, despite a significant decrease in Gulf Coast raw oyster production, 18 people died and another 14 became seriously ill after eating Vibrio vulnificus- contaminated raw oysters from the Gulf Coast.5 Last year, Vibrio vulnificus again caused 18 deaths and 14 additional illnesses, the vast majority of which were attributed to Gulf Coast raw oysters. That brings the total number of illnesses since 1989 caused by Vibrio vulnificus-contaminated raw shellfish to 225, of which 118 resulted in death.

     Between 12 million and 30 million Americans have medical conditions that make them especially vulnerable to Vibrio vulnificus infection. To protect those consumers, FDA should immediately adopt the performance standard proposed by CSPI. The proposed standard would provide a strong incentive for the industry to develop and use effective post-harvest treatments — the only sure way to eliminate the naturally occurring pathogen from raw shellfish. In addition, this action would not deny consumers raw shellfish from harvest waters that are free from Vibrio vulnificus. Instead, it would make any unsafe shellfish safe to eat.

     We urge FDA to adopt the proposed standard now, before this year’s deadly harvest gets underway. Deaths and illnesses from Vibrio vulnificus-contaminated raw shellfish can be prevented, if the agency acts swiftly to require processors to use available technologies to eliminate the pathogen from their products.

     Thank you for your attention to this pressing and long unaddressed public-health problem.

Sincerely,

Darren Mitchell
Senior Staff Attorney, Food Safety

Caroline Smith DeWaal
Director, Food Safety

On behalf of:Consumer Federation of America
Public Citizen
Safe Tables Our Priority

References

1: Research Triangle Institute, Economic Impacts of Requiring Post-Harvest Treatment of Oysters, Final Report, (March 2000) [hereinafter cited as RTI Report].

2: Food and Drug Administration, “Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products; Final Rule,” Federal Register, Vol. 60, No. 242 (1995) p. 65185-187. CSPI believes that FDA has underestimated the annual cost because it has undervalued the cost of each infection. According to CSPI’s estimates, the annual cost is at least $150 million. Center for Science in the Public Interest, Comments on Performance Standard for Vibrio vulnificus; Request for Comments, (submitted to FDA on April 21, 1999), pp. 23-25.

3: RTI Report, pp. 5-11 - 5-19.

4: To be sure, the RTI report does indicate that smaller shellfish processors may face economic difficulties in implementing post-harvest treatments. RTI Report, pp. 3-15 - 3-21. As RTI explains, the obvious solution to the problem would be for multiple small processing plants to enter cooperative agreements to centralize the processing of raw shellfish. Id., p. 3-18. However, the report cites historical concerns among some members of the industry regarding their ability to forge successful partnerships. Id., p. 3-19.

It should go without saying that the industry’s inability to cooperate is no excuse for failing to do what is necessary to protect consumers from Vibrio vulnificus-contaminated raw shellfish. If cooperation is necessary to prevent illness and deaths, the industry has a responsibility to its consumers to do so without further delay. FDA must not allow the industry to shirk that responsibility based upon prior “bad experience[s]” with cooperative processing facilities. RTI Report, p. 3-19.

5: Oyster production and illness/death data from 1997 and 1998 refute any claim that Gulf Coast shellfish have become safer since the 1995 implementation of the ISSC’s time/temperature controls. In 1997, the Gulf Coast oyster landings totaled 22,457,104 pounds and there were 20 total illnesses, including 10 deaths, attributed to Vibrio vulnificus-contaminated oysters. In 1998, production dropped to 17,936,025 pounds, while total illnesses climbed to 32 and deaths reached 18. (Oyster landings data obtained from the National Marine Fisheries Service.) Thus, despite a 20 percent decline in Gulf Coast oyster production in 1998, total illnesses actually increased by 60 percent and deaths increased by 80 percent that year. While it is premature to conclude that those figures mark any sort of trend (CSPI has been unable to obtain oyster landings data for 1999), they belie any claim that the ISSC’s time/temperature controls and consumer education efforts are solving the problem.