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


1. R.L. Shapiro, “The Role of Gulf Coast Oysters Harvested in Warmer Months in Vibrio vulnificus Infections in the United States, 1988-1996,” The Journal of Infectious Diseases, Vol. 178, p.752, 757 [hereinafter cited as Shapiro article]; W. Gary Hlady and Karl C. Klontz, “The Epidemiology of Vibrio Infections in Florida, 1983- 1993,” Journal of Infectious Diseases, Vol. 173 (1996), p. 1176, 1180 [hereinafter Hlady and Klontz article (1996)] (“Virtually 100% of Gulf Coast oysters harvested during warm weather months contain this organism.”); Dr. Mark Tamplin, “The Ecology of Vibrio vulnificus,” Proceedings of the 1994 Vibrio vulnificus Workshop, (Washington, DC: Department of Health and Human Services, 1994), p. 80 (“In other studies, V. vulnificus levels in 20 individual oysters from the Gulf of Mexico were determined. It was found that if the temperature and salinity were favorable, Vibrio vulnificus was present in all specimens.”). The organism has also been isolated in shellfish harvested from Atlantic and Pacific waters. “Vibrio vulnificus Infections Associated with Eating Raw Oysters—Los Angeles, 1996,” Morbidity and Mortality Weekly Report, Vol. 45, No. 29 (July 26, 1996), p. 621, 623 [hereinafter cited as MMWR article]. However, nearly all V. vulnificus illnesses linked to raw shellfish consumption and traceable to the harvest site have been traced to oysters harvested from the Gulf of Mexico. MMWR article (noting that in a 5-year FDA and state investigation of oyster-related V. vulnificus illnesses occurring outside the Gulf Coast states, all of the suspect oysters that could be traced to the harvest site came from the Gulf of Mexico). See also, Food and Drug Administration, “Vibrio vulnificus and Vibrio parahaemolyticus in Retail Shell Oysters: A National Survey, June 1998-July 1999,” (Apr. 3, 2000), p. 14 [hereinafter cited as FDA Retail Survey] (“On the other hand, retail level oysters harvested in the Mid-Atlantic States occasionally had V. vulnificus densities as high as those found in Gulf Coast oysters during summer months and V. vulnificus illnesses have rarely been associated with commercially harvested Mid-Atlantic oysters. Therefore, it is probable that other factors (i.e., strain differences, differences in production and consumption patterns) have an effect on the risk and/or occurrence of illness.”).

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. 65096, 65186, Table 6a; Paul S. Mead et al., “Food-Related Illness and Death in the United States,” Emerging Infectious Diseases Vol. 5, No. 5 [hereinafter cited as Mead article].

3. Eric Mouzin et al., “Prevention of Vibrio vulnificus Infections: Assessment of Regulatory Educational Strategies,” Journal of the American Medical Association, Vol. 278, No. 7 (1997), p. 576 [hereinafter cited as Mouzin article] (“[T]he high mortality ratio of septicemic infections [is] established at >50%.”); see also, e.g., W. Gary Hlady, “Vibrio Infections Associated with Raw Oyster Consumption in Florida, 1981-1994,” Journal of Food Protection, Vol. 60, No. 4 (1997), p. 353, 355 [hereinafter cited as Hlady article (1997)] (Of the 78 people who were hospitalized with primary septicemia due to infection with Vibrio vulnificus, 44 (54 percent) died.).

4. 4. W. Gary Hlady, “Vibrio vulnificus from Raw Oysters: A Leading Cause of Reported Deaths from Foodborne Illness,” Testimony Before the Human Resources and Intergovernmental Relations Subcommittee of the House Committee on Government Operations, (May 25, 1994) [hereinafter cited as Hlady testimony] (“Vibrio vulnificus [is] one of the most deadly foodborne illnesses known and the single leading cause of reported deaths from foodborne illness in Florida.”); Paul A. Blake, “Vibrios on the Half Shell: What the Walrus and the Carpenter Didn’t Know,” Annals of Internal Medicine, Vol. 99, No. 4 (1983), p. 558 [hereinafter cited as Blake article] (“Vibrio vulnificus is a particularly virulent organism, especially in compromised patients.”).

5. Memorandum by Karl C. Klontz, Food and Drug Administration Medical Officer, to Philip Spiller, Director, Office of Seafood, “Estimated number of persons at increased risk for Vibrio vulnificus septicemia,” Nov. 21, 1997 [hereinafter cited as Klontz memo] (“the numbers add up to a “low end estimate of 11,914,000 and a “high end” estimate of 29,859,000").

6. Shapiro article, pp. 752-9; see also, K. Klontz et al., “Syndromes of Vibrio vulnificus Infections: Clinical and Epidemiologic Features in Florida Cases, 1981-1987,” Annals of Internal Medicine, (Aug. 15, 1988), pp. 318-23 [hereinafter cited as Klontz article (1988)]; Cynthia Whitman, “Overview of the Important Clinical and Epidemiologic Aspects of Vibrio vulnificus Infections,” Proceedings of the 1994 Vibrio vulnificus Workshop, (Washington, DC: Department of Health and Human Services, 1994), p. 15 [hereinafter cited as Whitman presentation] (“Host susceptibility plays an important role in Vibrio vulnificus-related] primary septicemia and wound infection.”).

7. W. Gary Hlady and Karl C. Klontz, "The Epidemiology of Vibrio Infections in Florida, 1981-1993," The Journal of Infectious Diseases, Vol. 173 (1996), p. 1176 [hereinafter cited as Hlady and Klontz article (1996)] ("In the United States, Vibrio infections are most common in states bordering the Gulf of Mexico."); Interstate Shellfish Sanitation Conference, Issue No. 94-257, submitted by U.S. Food and Drug Administration, July 14, 1994 ("Mortality cases in the U.S. have a decidedly regional source and seasonal occurrence; virtually all known cases have involved raw Gulf Coast oysters, with warmer periods accounting for the large majority of cases.")

8. Some state and local public-health officials have called for stronger regulations. For example, the Florida Director of Communicable Disease Epidemiology told Congress in 1994: "[T]here is a need for the Federal government to establish tolerance/action levels for Vibrio vulnificus in oysters and to promote the development of practices and procedures to assure that all oysters reaching the marketplace meet consumer expectations for food safety." Hlady testimony. Similarly, a Los Angeles County public-health official has stated: "Our data show possibly serious limitations to current regulatory and educational strategies. . . . Current regulatory measures are limited to education and to refrigeration of oysters after harvesting. . . .We know that refrigeration alone does not kill all organisms, and in hosts with chronic liver disease, only a few bacteria may be required to initiate infection. Because at-risk persons may not be willing to listen to and act on preventive measures, restricting the sale of raw oysters harvested from warm waters to the colder months (November-April) could be considered by health officials." Mouzin article, p. 578.

9. For the purposes of this report, the term, "shellfish," is used to describe bi-valve molluscan shellfish-oysters, clams, and mussels.

10. Food and Drug Administration, Shellfish-Related Vibrio vulnificus Cases/Deaths, 1989-2000 [hereinafter cited as FDA Shellfish V.v. Data] (The FDA records contain the following information: date and state of consumption, age and state of victim, illness on-set date, status-alive or dead, suspect product, product origin-state and harvest area, existence of samples, presence or absence of preexisting illness in the victim); see also, Hlady article (1997), p. 353 ("Oyster-associated Vibrio infections in the United States have resulted predominantly from eating raw oysters from the Gulf of Mexico.").

11. Greg Winter, "Gulf Coast Oyster Farmers Try Self-Regulation," New York Times, (May 27, 2001), p. C5 [hereinafter cited as Winter article] ("Since Vibrio vulnificus first became well known a decade ago, the price of Gulf Coast oysters has dropped nearly 30 percent, as demand has all but dried up in markets like Chicago and New York. That free fall occurred even as oyster harvests from the Gulf diminished, according to data from Louisiana State University, challenging the axiom that a dip in supply sends prices soaring."); Angelo DePaolo et al., "Evaluation of an alkaline phosphatase-labeled DNA probe for enumeration of Vibrio vulnificus in Gulf Coast oysters," Journal of Microbiological Methods, Vol. 29 (1997), p. 115 [hereinafter cited as DePaolo article] ("While foodborne infections are relatively rare (mean of 17.4 cases per year from 1989 to 1995 in the USA), their severity has resulted in considerable public health concern and economic damage to the shellfish industry."); see also, M.E. Lopez-Caballero et al., "Oyster Preservation by High-Pressure Treatment," Journal of Food Protection, Vol. 63, No. 2 (2000), p. 196 [hereinafter cited as Lopez-Caballero article].

12. Winter article ("Only about $40 million worth of oysters, a third of the nation’s harvest, is pulled out of the Gulf of Mexico every year."); see also, National Oceanic and Atmospheric Administration, National Marine Fisheries Service, Marine Commercial Landings, available at [hereinafter cited as NMFS Data] (Data from 1999 are the most recent available on this website. Data from 2000 commercial landings will not be available until summer 2001).

13. For the purposes of this report, "warmer months" specifically includes the months of April through October. See, e.g., Food and Drug Administration, Division of Special Programs, Office of Seafood, Options Paper: Options for Reducing V. vulnificus Illnesses Associated with Oysters, (July 1994) [hereinafter cited as FDA Options Paper] ("About 85 percent of all traceable reported deaths from V. vulnificus infections have been directly associated with to [sic] the consumption of raw oysters harvested from the Gulf of Mexico during the months of April - October.").

14. Mr. Rosenwald’s death certificate reads "cardiac arrest" because the stool and blood culture test results were not available at the time that the death certificate was prepared. The pathology reports indicate the presence of Vibrio vulnificus. Vicki Peal, personal communication (June 15, 2001). This is not uncommon. One study, linking Vibrio vulnificus surveillance records to death certificates and coding data found that Vibrio vulnificus was not recorded on 55 percent of the pertinent death certificates and was misclassified on another 6 percent of death certificates. N. Banatvala et al., "Vibrio vulnificus infection reporting on death certificates: the invisible impact of an often fatal infection," Epidemiol. Infect., Vol. 118 (1997), pp. 221, 222-24 ("It is highly likely that a number of deaths from V. vulnificus infection are not diagnosed, and when diagnosed, only a small proportion are recorded on the certificate.").

15. Curtis Morgan, "Shell Shock," The Miami Herald, Tropic, July 25, 1993, p. 12, 13; Hlady article (1997), p. 355 (For example, "[r]aw oysters contaminated with Vibrio organisms from the Gulf of Mexico are the most common food associated deaths from food-borne illness in Florida.").

16. Whitman presentation, pp. 14-5 ("The mainstays of medical treatment for vulnificus infection are prompt antimicrobial therapy and supportive care. . . Case reviews have shown a median time period from hospital admission to death of 48 hours or less. This emphasizes the limited effectiveness of treatment and the importance of prevention."); Blake article, p. 559 ("The experience of one group has led them to advocate early and vigorous debridement in addition to antimicrobial therapy in the particularly virulent V. vulnificus infections.").

17. FDA Shellfish V.v. Data.

18. Hlady article (1997), p. 356 ("[T]he large majority (74%) of patients with raw-oyster-associated Vibrio gastroenteritis had no underlying conditions. . . The risk of Vibrio gastroenteritis seems to be equally shared among all those who eat raw oysters.").

19. Klontz memo.

20. Data from Florida shows that people with liver disease who consumed raw oysters had an annual rate of V. vulnificus infection 80 times the rate for adults without liver disease who ate raw oysters. W. Gary Hlady, "Vibrio vulnificus from raw oysters: leading cause of reported deaths from foodborne illness in Florida," Journal of Florida Medical Association, Vol. 80 (1993), pp. 537-38.

21. Klontz memo. "Host factors such as liver disease, immune deficiency, diabetes mellitus, achlorhydria, and previous gastric surgery may facilitate disease occurrence." Jean-Claude Desenclos et al., "The Risk of Vibrio Illness in the Florida Raw Oyster Eating Population, 1981-1988," American Journal of Epidemiology, Vol. 134, No. 3 (1991), p. 290 [hereinafter cited as Desenclos article]. At least one study has indicated that the leading risk factor for Vibrio vulnificus-related septicemia is liver disease, followed by previous gastric surgery, and diabetes mellitus. Desenclos article, p. 293.

22. Hemochromatosis is a condition in which the body accumulates excess amounts of iron. Hereditary hemo-chromatosis is one of the most common genetic diseases in humans. In the United States, as many as one million people have evidence of hemochromatosis, and up to one in every ten people may carry the gene for the disorder.

23. Klontz article (1988), p. 320 (In a study of 38 individuals with primary septicemia, "[s]epticemic illness occurred in 2 previously healthy persons.").

24. N. Daniels and A. Shafaie, "A Review of Pathogenic Vibrio Infections for Clinicians," Infect. Med., Vol. 17, No. 10 (2000), pp. 665-85 [hereinafter cited as Daniels article], citing, D.G. Hollis et al., "Halophilic Vibrio sp. isolated from blood cultures," J. Clin. Microbiol., Vol 3 (1976), p. 425. In 1994, for example, Dr. Cynthia Whitman of the U.S. Centers for Disease Control and Prevention warned: "The number of [Vibrio vulnificus] cases reported each year has remained steadily in the range of 15 to 30 per year. Based on this data, vulnificus infection appears likely to remain an ongoing, persistent problem."). Whitman presentation, p. 14.

25. Some experts have noted that consumption of just one Vibrio vulnificus-tainted raw oyster can be fatal to some individuals. Whitman presentation, p. 19 ("The number of raw oysters consumed by patients who died varied from one to a pint of shucked oysters. It is important that consumption of even one oyster proved fatal.").

26. FDA Shellfish V.v. Data.

27. Whitman presentation, p. 19 ("There is a marked seasonal increase in vulnificus infections during the warm summer months. Eighty-eight percent of all vulnificus infections occur between May and October."); Karl C. Klontz et al., "Raw Oyster-Associated Vibrio Infections: Linking Epidemiologic Data with Laboratory Testing of Oysters Obtained from a Retail Outlet," Journal of Food Protection, Vol. 56, No. 12 (1993), p. 977, 978 (citing a 1982 study and stating, "Consistent with previous studies of oysters obtained from the Gulf coast, we recovered V. vulnificus most readily during the summer months, when the waters are warmest.").

28. Whitman presentation, pp. 19-20 ("The marked seasonality of vulnificus infections provides a key time period for intervention. . . . Recommendations . . . Decrease raw oyster consumption during the warm summer months between May and October. A variety of methods to achieve this goal should be considered, including closing oyster beds during this time, and posting consumer advisories."); Hlady testimony ("[L]imiting harvesting of oysters to the cold weather months or assuring that all oysters harvested during warm weather months are cooked may be effective preventive measures."); Hlady article (1997), p. 356 (noting that seasonal marketing restrictions "may have a high potential to decrease the risk of illness").

29. From 1972 to the late 1990’s, summer oyster harvesting in the Gulf increased from 15 percent to >40 percent as a percentage of total production. Shapiro article, p. 757 (citing, National Marine Fisheries Service, Fishery Statistics and Economics Division, 1998, personal communication). Government data indicate that the state of Mississippi did not harvest Eastern oysters in 1998 and 1999. NMFS Data. NB: An FDA document produced in 1994 did not include Alabama in the list of states harvesting oysters during summer months. FDA Options Paper ("The States of Florida, Louisiana and Texas harvest shellfish from the Gulf of Mexico in the summer months.") However, more recent government data indicate that the state of Alabama has at least some oyster harvesting during warmer months. NMFS Data.

30. Three states-Florida, California, and Louisiana-require consumer advisory statements to be posted at the point of purchase of raw oysters. Babgaleh B. Timbo et al., "Raw shellfish consumption and warning labels: results from the 1993 Texas Behavioral Risk Factor Surveillance System," Texas Medicine, (Nov. 1996), p. 52.

31. See, e.g., Winter article; Hlady article (1997), p. 356 ("Laboratory studies have also suggested processes that may likewise be effective in reducing the risk of V. vulnificus infection from raw oyster consumption.").

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

33. Rebecca Osvath, "Shellfish industry calls postharvest treatment goal ’unattainable’," Food Chemical News, July 24, 2000, p. 18.

34. The FDA also relies on two other federal-state cooperative programs on food safety, the National Conference on Interstate Milk Shipments (NCIMS) to develop safety standards governing Grade A milk products and the Conference for Food Protection (CFP) to develop standards for food products sold by restaurants, supermarkets, and other retail establishments. All three cooperative programs are structured similarly and suffer from flaws that leave consumers vulnerable to foodborne illness.

35. The bacteria are not linked to pollution. Molluscan shellfish become contaminated with Vibrio vulnificus during their normal feeding process, as they filter large volumes of marine water in search of nutrients. Hlady article (1997), p. 353.

36. "Vibrio vulnificus Infections Associated with Eating Raw Oysters--Los Angeles, 1996," Morbidity and Mortality Weekly Report, Vol. 45, No. 29 (July 26, 1996), pp. 621-624.

37. Vibrio vulnificus-induced primary septicemia occurs when the bacteria invade the victim’s bloodstream. Early symptoms include fever and chills, usually accompanied by nausea, vomiting, and diarrhea. Eventually, blood pressure drops sharply, leading in many cases to intractable shock and death. Most patients also develop painful skin lesions. Whitman presentation, p. 14; see also, Daniels article.

38. One study reported a mortality rate of 61 percent among patients with Vibrio vulnificus-related primary septicemia. Shapiro article, p. 756.

39. And because our population is aging, and the incidence of some of the predisposing conditions is increasing, the deaths and illnesses related to Vibrio vulnificus are likely to rise in the coming years if current practices continue. See, e.g., Desenclos article, p. 294 ("the prevalence rates [of pertinent preexisting conditions] tended to increase by age").

40. Food and Drug Administration, Bad Bug Book, Vibrio vulnificus, available at

41. MMWR article, p. 623.

42. Hlady article (1997), p. 353.

43. Daniels article, pp. 665-85. One scientist estimated that Vibrio vulnificus wound infections represented about a third of the vulnificus cases but only 8 percent of the deaths. Whitman presentation, p. 17.

44. Daniels article, pp. 665-85.

45. From 1981-1988, the Florida reporting system documented 42 Vibrio vulnificus-related septicemia cases and 6 gastrointestinal illnesses linked to raw oyster consumption. Desenclos article, p. 292, Table 1.

46. Hlady and Klontz article, p. 1176. In 1988, the states of Alabama, Florida, Louisiana, and Texas developed and implemented a regional surveillance program for the pathogen. Mississippi joined the program the following year. Whitman presentation, p. 16.

47. FDA Shellfish V.v. Data.

48. Food and Drug Administration, "Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products," Federal Register, Vol. 60, No. 242, Dec. 18, 1995, p. 65096, 65186. In contrast, the value of the annual harvest of Gulf Coast oysters sold for raw consumption amounts to only about $20 million. NMFS Data; Winter article, ("Only about $40 million worth of oysters, a third of the nation’s harvest, is pulled out of the Gulf of Mexico every year."); RTI Report, p. 2-9 (assuming that half of all Gulf Coast oysters are sold for raw consumption based on industry information).

49. Little is known about the pathogen’s "infectious dose"-the number of bacteria needed to cause illness-although some evidence suggests that as few as 100 organisms can trigger septicemia in especially vulnerable people.

50. Blake article, p. 559 ("Those most commonly isolated pathogenic Vibrio species ( . . . [including] V. vulnificus) have a markedly seasonal distribution, with most of the infections occurring during summer and fall.").

51. Some members of the oyster industry claim that the texture of post-harvest treated oysters is different than untreated oysters. Charlotte Christin, CSPI Staff Attorney, Notes from ISSC 2000 Annual Meeting, July 15-20, 2000. However, researchers who studied the hydrostatic pressurization method of treating oysters reported that "[a]fter high-pressure treatment, the oyster was slightly more voluminous and juicy." Lopez-Caballero article, p. 200.

52. Earlier this year, the state of Florida released a voluntary plan to control Vibrio vulnificus in shellfish. The Florida plan is loosely based on a proposal considered at the 2000 Interstate Shellfish Sanitation Conference meeting, except that the Florida plan is voluntary, does not specify when regulatory controls would be required, and does not set Vibrio vulnificus illness-reduction goals. Florida Department of Agriculture and Consumer Services, Interim Florida Voluntary Vibrio vulnificus Risk-Reduction Plan for Shellfish. (Mar. 8, 2001), available at

53. 21 U.S.C. § 331.

54. 42 U.S.C. § 264. A "communicable disease" includes one that can be transmitted directly from an infected animal to a person. 21 C.F.R. § 1240.3(b). In this instance, Vibrio vulnificus is transmitted from oysters that have bacteria in their intestinal tracts directly to humans who consume the contaminated oysters raw.

55. The FFDCA provides that foods may be "adulterated" in a variety of ways. 21 U.S.C. § 342. For the purposes of this report, the relevant subparagraph states that a food is adulterated when it "contains any poisonous or deleterious substance which may render it injurious to health." 21 U.S.C. § 342(a)(1).

56. United States v. Anderson Seafoods, Inc., 622 F.2d 157, 159-61 (5th Cir. 1980).

57. Interstate Shellfish Sanitation Conference Executive Office, "Risk Reduction Measures for V. vulnificus," Aug. 1995, p. 14. See also, Patricia S. Schwartz, PhD, Center for Food Safety and Applied Nutrition, Food and Drug Administration, FDA Response to ISSC Executive Office’s Risk Reduction Measures for V. vulnificus, Aug. 17, 1995 [hereinafter cited as FDA Response to ISSC].

58. FDA Retail Survey, p. 13.

59. Food and Drug Administration, "Requirements Affecting Raw Milk for Human Consumption in Interstate Commerce; Final Rule," Federal Register, Vol. 52, No. 153 (1987), pp. 29511-29512. A similar federal-state cooperative conference is used to regulate the milk industry.

60. Food and Drug Administration, "Hazard Analysis and Critical Control Point (HACCP); Procedures for the Safe and Sanitary Processing and Importing of Juice; Final Rule," Federal Register, Vol. 66, No. 13 (2001), pp. 6128-6202 (retail establishments where packaged juice is made and sold directly to customers do not have to treat their juices).

61. Most of the requirements are set out in the Administrative Procedure Act (APA), 5 U.S.C. § 551 et seq., and in judicial decisions interpreting the APA.

62. The Model Ordinance is a "guidance document," not a regulation; therefore, it is not legally binding. Food and Drug Administration, "National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish; Availability," Federal Register, Vol. 63, No. 137 (July 17, 1998), p. 38660. The Model Ordinance was formerly known as the NSSP Manual of Operations.

63. Interstate Shellfish Sanitation Conference, Constitution, By-Laws and Procedures, at Procedures II and I [hereinafter cited as ISSC Constitution, By-Laws, and Procedures]. Accord, Food and Drug Administration, Compliance Policy Guide No. 7158.04, Memorandum of Understanding Between the Interstate Shellfish Sanitation Conference and the Food and Drug Administration, (April 1, 1984), Prov. IV.A.7, IV.B.1, and IV.C.2 [hereinafter cited as ISSC MOU].

64. Food and Drug Administration, "National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish; Availability," Federal Register, Vol. 63, No. 137, (July 17, 1998), pp. 38659-60 ("FDA periodically publishes revisions of the Manuals of Operation based on resolutions adopted by voting delegates of the ISSC and with which FDA concurs."). Thus, any proposed change must be approved by ISSC delegates and accepted by the FDA.

65. After 2001, the ISSC will change to biennial meetings.

66. ISSC By-Laws, Art. 3, §§ 2-4.

67. ISSC By-Laws, Art. 1 § 2.

68. ISSC By-Laws, Art. 1, § 3.

69. ISSC By-Laws, Art. 2, §§ 1-3.

70. ISSC Constitution, Art. 11, § 3(h). Task forces also may assign an issue to a committee for additional consideration after the annual meeting has ended.

71. ISSC Constitution, Art. 11, § 3(b).

72. After receiving the transcript from the General Assembly, the FDA has 60 days in which to notify the ISSC chair regarding its concurrence or non-concurrence with all proposals adopted by the voting delegates. In so doing, the agency assesses whether the proposed changes are consistent with federal law, regulations, and FDA policy. ISSC Procedures, Procedure X.

73. ISSC Procedures, Procedure X, § 2. The FDA publishes the Model Ordinance every two years.

74. ISSC Procedures, Procedure X, §§ 3-4.

75. ISSC Constitution, Art. 5, § 1.

76. ISSC Constitution, Art. 5, § 1.

77. Before the 2000 annual meeting, representatives of consumer, environmental, and health organizations were not eligible for membership on the ISSC executive board. Only at the latest annual meeting, held in August 2000, did the voting delegates decide to add a non-voting "consumer advisory" member to the executive board. As originally proposed, that member would have had full voting rights; however, during the meeting the position was recast as non-voting. Interstate Shellfish Sanitation Conference, Summary of 2000 Actions, Issue No. 00-303, p. 92.

78. Letter from Diane E. Thompson, Associate Commissioner for Legislative Affairs, Food and Drug Administration, to Representative Edolphus Towns, Chairman, Subcommittee on Human Resources and Intergovernmental Relations, Dec. 14, 1994, p. 2.

79. The 1999 Gulf Coast oyster harvest-which was used for both raw and cooked product-was worth only $30.7 million. NMFS Data.

80. RTI Report, p. 2-9 (assuming that half of all Gulf Coast oysters are sold for raw consumption based on industry information).

81. NMFS Data.

82. NMFS Data.

83. NMFS Data; see also, RTI Report, p. 2-4 (for comparable findings based on 1997 data).

84. Winter article; see also, DePaola article, p. 115 ("While foodborne infections are relatively rare (mean of 17.4 cases per year from 1989 to 1995 in the USA), their severity has resulted in considerable public health concern and economic damage to the shellfish industry.").

85. Jack Reed, "Their World Is an Oyster," St. Petersburg Times, May 2, 1993, p. B1 [hereinafter cited as Reed article].

86. Reed article.

87. William Booth, "After 9 Deaths in Florida, Oyster Industry Confronts Raw Fear," Washington Post, Apr. 19, 1993, pp. A3 [hereinafter cited as Booth article].

88. Reed article. Similarly, when the state of California enacted regulations requiring warnings about raw oysters to be posted in restaurants, "considerable concern was expressed by seafood and restaurant industries, especially in Gulf Coast states, about likely negative economic impact of the new regulations on their businesses." Mouzin article, p. 576.

89. Jim Yardley, "Half-Shell Debate: Stormy seas surround oyster ban," The Atlanta Journal and Constitution, Aug. 6, 1994, p. A3.

90. Booth article.

91. Booth article.

92. Carlos Campos, "Fighting the Oyster Scare," The Times-Picayune, Aug. 3, 1993, p. C1.

93. Lauren Neergaard, "FDA Tries $500,000 Campaign to Alert Americans to Oyster Risk," Associated Press, June 19, 1995.

94. Richard E. Thompson, Texas Dept. Of Health (Past Chairman of the ISSC), Evolution of the Vibrio vulnificus Issue (unpublished) (Dec. 1995), p. 2 [hereinafter cited as Thompson Report].

95. The California official called for a restriction on sales of shellfish harvested during the months of April to October and a year-round restriction on sales of all Gulf Coast shellfish unless the states required the shellfish to be maintained at 40F to inhibit multiplication of the bacteria. Thompson Report, p. 3.

96. Thompson Report, p. 3.

97. The workshop was co-sponsored by the ISSC and the National Marine Fisheries Service. Thompson Report, p. 10.

98. Letter from Thomas J. Billy, Office of Seafood, Food and Drug Administration, to Ken Moore, ISSC, July 19, 1994, pp. 2-3.

99. FDA Options Paper.

100. FDA Options Paper, p. 8.

101. Rep. Tauzin now is a member of the Republican Party.

102. Letter from United States Senators J. Bennett Johnston, Trent Lott, John Breaux, and Thad Cochran, and United States Representatives Earl Hutto, Robert Livingston, Greg Laughlin, Solomon Ortiz, Billy Tauzin, William Jefferson, Pete Peterson, Sonny Callahan, and Gene Taylor to Ken Moore, Interstate Shellfish Sanitation Conference Executive Director, (Aug. 5, 1994).

103. Interstate Shellfish Sanitation Conference, Transcript of the Closing General Assembly of the 12th Annual Meeting, (Aug. 11, 1994), pp. 62-75. At the meeting, a majority of Task Force II members voted to delay consideration of Option 2 until the next annual meeting. But in a "minority report" some Task Force II members recommended adopting Option 2 with an implementation date of January 1, 1995. During the debate, one delegate expressed the frustrations of many: "I’ve been coming to this Conference for five years. Each year, we’ve brought this issue forward, the State of Washington, along with other states. Each year, it’s sent back to committee. I’ve been on committee in several conferences. The same thing’s happened; there’s been no action." 1994 Transcript, p. 58 (remarks of Maryanne Guichard, Washington State Department of Health).

104. Thompson Report, p. 2.

105. Rep. Tauzin now is a member of the Republican Party.

106. Letter from United States Senators J. Bennett Johnston and John Breaux, and United States Representatives Bob Livingston, Jimmy Hayes, Billy Tauzin, and William Jefferson, to David A. Kessler, Commissioner, Food and Drug Administration, (July 26, 1994).

107. The agency signaled its displeasure by formally refusing to concur with the ISSC’s vote on Option #2.

108. Memorandum by Richard Thompson, Chair of ISSC Consumer Protection Committee, Feb. 22, 1995, p. 5 (Attachment to ISSC Issue 94-257, as prepared for 1995 ISSC Annual Meeting).

109. FDA Response to ISSC.

110. FDA Response to ISSC.

111. The FDA pointed out that Vibrio vulnificus can multiply 10- to 100-fold while on the harvesting vessel during warm weather. Letter from Patricia S. Schwartz, PhD, Center for Food Safety and Applied Nutrition, Food and Drug Administration, to Ken B. Moore, Executive Director, Interstate Shellfish Sanitation Conference, June 27, 1995, p. 3; FDA Retail Survey, p. 13; see also, DePaolo article, p. 119 ("[O]n-board refrigeration is rarely available on Gulf Coast harvest vessels and V. vulnificus multiplies rapidly in unrefrigerated oysters that are exposed to warm outdoor ambient temperatures.").

112. Jeff Hardy, "Coast fights to keep summer oyster supply," Mobile Register, March 8, 1995, pp. 1B-2B [hereinafter cited as Hardy article].

113. Hardy article.

114. Joanna Weiss, "FDA May Ban Raw Oysters; Area Fishermen Fear for Jobs," The Times-Picayune, Aug. 23, 1995, p. 1.

115. The FDA, in turn, offered a counterproposal that would have established a time-temperature matrix based on water temperatures rather than ambient air temperatures and would have required refrigeration of shellfish within 2 hours of harvest at times when the waters reached their highest temperatures. FDA Response to ISSC.

116. A letter from the Gulf Oyster Industry Council reports that the FDA had "indicated that if they were forced to present their data at the Task Force they would be forced to support their response to the ISSC’s proposal which involved 2 hours time to refrigeration." Letter From Mike Voisin, Interim Chairman, Gulf Oyster Industry Council (GOIC), to GOIC members, (attached cover sheet dated Aug. 30, 1995). Thus, the letter reveals that during the negotiations the FDA had agreed to ignore its own data-which showed the need for a two hour (or less) time-to-refrigeration requirement--and support a longer time-to-refrigeration requirement to appease the Gulf Coast industry. A six hour time-to-refrigeration requirement ultimately was adopted.

117. Letter from Elizabeth Dahl, Staff Attorney, Center for Science in the Public Interest, to Donna Shalala, Secretary, Department of Health and Human Services, and Michael Friedman, M.D., Lead Deputy Commissioner, Food and Drug Administration, Nov. 12, 1997, pp. 3-4 (recounting discussions at the ISSC’s 1997 Annual Meeting).

118. Letter from Janice Oliver, Acting Director, Center for Food Safety and Applied Nutrition, Food and Drug Administration, to Elizabeth Dahl, Staff Attorney, Center for Science in the Public Interest, Jan. 20, 1998, pp. 5-7.

119. Interstate Shellfish Sanitation Conference, Issue Number 98-106, submitted by Linda Andrews, AmeriPure Oyster Company (May 11, 1998). In sum, the AmeriPure proposal revived the public-health principles of Option #2, but offered greater flexibility by using the new technologies to make contaminated shellfish safe. Id.

120. At the 1998 ISSC annual meeting, a majority of the task force members voted to refer the proposal to an ISSC committee for future discussion. That decision, reaffirmed by the voting delegates, effectively delayed any real progress on the issue until, at the very least, the 1999 annual meeting. Interstate Shellfish Sanitation Conference, Issue Number 98-106 (May 17, 1999).

121. The resolution stated that "a mandatory product performance standard for growing areas for Vibrio vulnificus in raw molluscan shellfish is inappropriate." Darren Mitchell, CSPI Staff Attorney, notes from Product Enhancement Committee meeting, July 18, 1999.

122. Interstate Shellfish Sanitation Conference, 1999 Product Enhancement Committee Report, (July 18, 1999).

123. A second Vibrio species, Vibrio parahaemolyticus, also infects molluscan shellfish and can sicken consumers. Unlike Vibrio vulnificus, however, Vibrio parahaemolyticus rarely causes primary septicemia. It does tend to cause large-scale outbreaks. For example, in 1997, Vibrio parahaemolyticus in oysters was linked to more than 200 illnesses and in 1998, caused more than 400 illnesses in 13 states. Center for Science in the Public Interest, Outbreak Alert! Closing the Gaps in Our Federal Food-Safety Net, (Washington, DC: Center for Science in the Public Interest), Aug. 2000, pp. 20-21.

124. Darren Mitchell, CSPI Staff Attorney, notes from General Assembly, July 23, 1999.

125. Interstate Shellfish Sanitation Conference, Issue No. 00-101/201/301, May 15, 2000 [hereinafter cited as ISSC Issue 00-101/201/301].

126. ISSC Issue 00-101/201/301.

127. ISSC Issue 00-101/201/301.

128. Rebecca Osvath, "Gulf State lawmakers opposed ISSC’s postharvest treatment goal for oysters," Food Chemical News, July 24, 2000, pp. 17-18.

129. The 2000 meeting was designated a "special" meeting by the ISSC’s executive board, with deliberations to be limited to just two specific topics: control of the Vibrio species in molluscan shellfish and the implementation of FDA’s Hazard Analysis and Critical Control Point (HACCP) program for seafood in conjunction with the National Shellfish Sanitation Program (NSSP). Ken Moore, Executive Director, Interstate Shellfish Sanitation Conference, Cover Letter on 2000 Issues, (Mar. 15, 2000).

130. Charlotte Christin, CSPI Staff Attorney, Notes from 2000 ISSC Annual Meeting, July 15-20, 2000.

131. Charlotte Christin, CSPI Staff Attorney, Notes from 2000 Joint Task Force Meeting, July 17, 2000; FDA Shellfish V.v. Data. The clams implicated in two of the seven deaths were not traceable. In four of the five deaths that could be traced, Gulf Coast clams were part of the victims’ meals. The remaining known, traceable death (and two of the six clam-related illnesses) involved Gulf Coast oysters, eaten together with clams from non-Gulf Coast states, such as North Carolina and Virginia. In three of the illnesses, clams harvested from Florida were part of the victims’ meals. In the remaining illness, clams harvested from North Carolina were linked to the illness. FDA Shellfish V.v. Data.

132. Charlotte Christin, CSPI Staff Attorney, Notes from 2000 ISSC Joint Task Force Meeting, July 18, 2000 [hereinafter cited as Christin Task Force Notes]. See also, Rebecca Osvath, "ISSC votes to delay implementation of Vibrio vulnificus control plan one year," Food Chemical News, July 24, 2000, pp. 16-17 [hereinafter cited as Osvath article].

133. Mead article.

134. Christin Task Force Notes.

135. Osvath article.

136. Osvath article.

137. Osvath article. Nancy Ridley had introduced the motion at the 1999 Annual Meeting to establish the VMC and served as its chair.

138. Osvath article, p. 17.


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