Source: http://www.cspinet.org/reports/vibrio_vulnificus/10.html
Timestamp: 2014-07-24 12:18:05
Document Index: 568861670

Matched Legal Cases: ['§ 331', '§ 264', '§\n1240', '§ 342', '§\n342', '§ 551', 'Art. 3', '§ 2', 'Art. 1', '§ 2', 'Art. 1', '§ 3', 'Art. 2', '§ 1', 'Art. 11', '§ 3', 'Art. 11', '§ 3', '§ 2', '§ 3', 'Art. 5', '§ 1', 'Art. 5', '§ 1']

XI. Endnotes
III. The FDA Plays Politics With Public Health
IV. The FDA is Charged With Protecting Consumers Against
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
VIII. How The FDA And ISSC Failed To Protect Consumers
IX. Timeline
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
http://www.st.nmfs.gov/webplcomm/plsql/webst1.MF_ANNUAL_LANDINGS.RESULTS [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.
http://www.cdc.gov/nccdphp/dnpa/hemochromatosis.html 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 http://vm.cfsan.fda.gov/~mow/chap10.html. 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
http://www.issc.org/issc/News/FL-Vv-Risk-Reduction-Plan/htm/default.htm. 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. <<Previous Next>>
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