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United States Government Accountability Office: 
GAO: 

Report to the Honorable Rosa L. DeLauro, House of Representatives: 

September 2011: 

Food Safety: 

FDA Needs to Reassess Its Approach to Reducing an Illness Caused by 
Eating Raw Oysters: 

GAO-11-607: 

GAO Highlights: 

Highlights of GAO-11-607, a report to the Honorable Rosa L. DeLauro, 
House of Representatives. 

Why GAO Did This Study: 

Vibrio vulnificus (V. vulnificus) is a bacterium that occurs naturally 
in the Gulf of Mexico. On average, since 2000, about 32 individuals a 
year in the United States have become ill from eating raw or 
undercooked oysters containing V. vulnificus, and about half have 
died. The Food and Drug Administration (FDA) is responsible for 
ensuring oyster safety and works with the Interstate Shellfish 
Sanitation Conference (ISSC), which includes representatives from FDA, 
states, and the shellfish industry to establish guidelines for 
sanitary control of the shellfish industry. GAO was asked to determine 
the extent to which FDA and the ISSC agree on the V. vulnificus 
illness reduction goal, use a credible approach to measure progress 
toward the illness rate reduction goal, have evaluated the 
effectiveness of their actions in reducing V. vulnificus illnesses, 
and whether the Gulf Coast oyster industry has adequate capacity to 
postharvest process oysters harvested April through October. GAO 
reviewed data and documents and interviewed officials in FDA, the 
ISSC, Florida, Louisiana, and Texas. 

What GAO Found: 

FDA and the ISSC do not agree on a common V. vulnificus illness 
reduction goal. In October 2009, FDA announced its intention to change 
its approach to V. vulnificus illnesses from reducing them to largely 
eliminating them. To do so, FDA would require states to use 
postharvest processing methods, which include a mild heat treatment 
known as low temperature pasteurization. FDA’s announced approach was 
a change from the 60 percent illness rate reduction goal established 
by the ISSC in 2001, with FDA concurrence. In a November 2009 letter 
to FDA, the ISSC expressed disappointment that FDA had not followed a 
1984 memorandum of understanding that calls for FDA and the ISSC to 
consult on such matters. If FDA and the ISSC are not in agreement on 
the illness reduction goal and strategies to achieve it, it will be 
difficult for the Gulf Coast states to move forward to significantly 
reduce the number of consumption-related V. vulnificus illnesses. 

The approach FDA and the ISSC have been using to measure progress 
toward the previously agreed upon V. vulnificus illness rate reduction 
goal established in 2001 has limitations that undermine its 
credibility. For example, the ISSC continues to include California’s 
results in its illness rate reduction calculation along with Florida, 
Louisiana, and Texas. Doing so overstates the effectiveness of 
consumer education and time and temperature controls-—FDA’s and the 
ISSC’s primary strategies for reducing V. vulnificus illnesses-—
because California, unlike these other states, requires that all raw 
Gulf Coast oysters harvested during the summer and sold in the state 
be processed to reduce V. vulnificus to nondetectable levels, which 
has reduced V. vulnificus illnesses to nearly zero. 

FDA and the ISSC have taken few steps to evaluate the effectiveness of 
their consumer education efforts since 2004. Likewise, they have not 
directly evaluated the effectiveness of the time and temperature 
controls implemented in 2010, which call for harvesters to ensure that 
oysters are cooled to specific temperatures within certain times to 
reduce V. vulnificus growth. Although data are not available, our 
discussions with state and oyster industry officials suggest 100 
percent compliance with the controls is highly unlikely. Moreover, our 
analysis shows-—even assuming 80 percent compliance in the summer 
months—-it is unlikely that these controls will lead to the level of 
illness reduction estimated by a model developed by FDA. 

The Gulf Coast oyster industry does not have sufficient capacity to 
process all of its oysters intended for raw consumption that are 
harvested from April through October to reduce V. vulnificus to 
nondetectable levels, according to an FDA-commissioned report. The 
report concluded that it will take a minimum of 2 to 3 years to 
develop the infrastructure needed to process these oysters. However, 
the report has some limitations that call into question the 
completeness of its cost and timeline estimates. For example, the 
report’s cost estimates did not include some construction costs and 
costs associated with purchasing land needed to expand existing 
processing facilities or build new ones. Without this information, the 
full cost of developing sufficient processing capacity will not be 
known. 

What GAO Recommends: 

GAO recommends that FDA work with the ISSC to agree on an illness 
reduction goal, improve its approach to measuring progress in reducing 
V. vulnificus illnesses, regularly evaluate its illness reduction 
strategies, and address the limitations in the FDA-commissioned 
report. FDA and the ISSC generally agreed with our recommendations. 

View [hyperlink, http://www.gao.gov/products/GAO-11-607] or key 
components. For more information, contact Lisa Shames at (202) 512-
3841 or shamesl@gao.gov. 

[End of section] 

Contents: 

Letter: 

Background: 

FDA and the ISSC Do Not Currently Agree on a V. Vulnificus Illness 
Reduction Goal: 

The Approach FDA and the ISSC Use for Measuring Progress toward Their 
Illness Rate Reduction Goal Has Limitations That Undermine Its 
Credibility: 

FDA and the ISSC Have Taken Few Steps to Evaluate the Effectiveness of 
Consumer Education and Time and Temperature Controls: 

Extent of Industry Compliance with Time and Temperature Controls Is 
Unknown: 

Extent of Illness Reduction from Time and Temperature Controls Depends 
on Compliance Levels: 

Adequate Capacity Does Not Exist to Use Postharvest Processing on Gulf 
Coast Oysters, and Questions Exist about the Feasibility of Developing 
Such Capacity: 

Conclusions: 

Recommendations for Executive Action: 

Agency Comments and Our Evaluation: 

Appendix I: Estimating the Impact of Time and Temperature Controls on 
the Number of Illnesses from V. Vulnificus: 

Appendix II: Comments from the Department of Health and Human Services: 

Appendix III: Comments from the Interstate Shellfish Sanitation 
Conference: 

Appendix IV: GAO Contact and Staff Acknowledgments: 

Tables: 

Table 1: Time and Temperature Controls Implemented by Florida, 
Louisiana, and Texas Beginning May 1, 2010: 

Table 2: Comparison of Estimates between WHO/FAO Risk Simulation Model 
and GAO Replication of the Model for July, August, and September: 

Table 3: Time and Temperature Controls for 2010, by State and Month: 

Table 4: Comparison of FDA's Risk Calculator and GAO's Modification of 
WHO/FAO Risk Simulation Model Concerning Estimated Number of V. 
Vulnificus Illnesses per 100,000 Servings of Oysters at Baseline: 

Table 5: Estimated Percentage Reduction in the Number of V. Vulnificus 
Illnesses as a Result of Time and Temperature Controls, by State and 
Month: 

Table 6: Probability That the Time and Temperature Controls Will 
Reduce V. Vulnificus Illnesses to the Number Estimated by FDA's Risk 
Calculator or Lower, by Estimated Compliance Rate: 

Figures: 

Figure 1: Gulf Coast States and Oyster Harvest Areas: 

Figure 2: Amount and Value of Oysters Harvested by Gulf Coast States 
in 2009: 

Figure 3: Total Number of V. Vulnificus Oyster Consumption-Related 
Illnesses Reported Nationally, by month, from 2000-2010: 

Figure 4: Number of V. Vulnificus Oyster Consumption-Related Illnesses 
Reported Nationally, by Year, from 2000-2010: 

Figure 5: Sample Log Sheet: 

Figure 6: Sample Oyster Labels: 

Figure 7: Estimated Reduction in the Number of V. Vulnificus Illnesses 
as a Result of Time and Temperature Controls for Louisiana in August: 

Figure 8: Key Components of WHO/FAO Risk Simulation Model and GAO 
Modifications: 

Abbreviations: 

CDC: Centers for Disease Control and Prevention: 

FDA Food and Drug Administration: 

ISSC: Interstate Shellfish Sanitation Conference: 

NOAA: National Oceanic and Atmospheric Administration: 

RTI: Research Triangle Institute International: 

V. vulnificus: Vibrio vulnificus: 

WHO/FAO: World Health Organization and the Food and Agriculture 
Organization: 

[End of section] 

United States Government Accountability Office: 
Washington, DC 20548: 

September 8, 2011: 

The Honorable Rosa L. DeLauro: 
House of Representatives: 

Dear Ms. DeLauro: 

Illnesses due to Vibrio vulnificus (V. vulnificus), a naturally 
occurring bacterium that is commonly found in oysters harvested from 
the Gulf of Mexico and that grows quickly--especially during warmer 
months (April through November)--are the most common cause of death 
from seafood consumption in the United States. Individuals with 
compromised immune systems can develop a severe and potentially fatal 
infection from eating raw or undercooked oysters contaminated with V. 
vulnificus. According to data provided by the Interstate Shellfish 
Sanitation Conference (ISSC)--a voluntary organization formed in 1982 
by state officials from 22 states to promote uniform national 
shellfish safety policies--the number of V. vulnificus illnesses 
associated with raw oyster consumption has averaged about 32 a year 
nationwide since 2000. V. vulnificus illnesses are fatal about 50 
percent of the time, according to the Centers for Disease Control and 
Prevention (CDC). 

Under ISSC procedures, FDA, the federal agency responsible for 
ensuring the safety of oysters and other shellfish, must concur with 
the ISSC's proposed shellfish safety policies before they can be 
incorporated into the National Shellfish Sanitation Program's 
shellfish safety guidelines.[Footnote 1] In 2001, the ISSC approved, 
with FDA concurrence, a change in the shellfish safety guidelines 
providing that individual states are to develop V. vulnificus risk 
management plans if two or more confirmed V. vulnificus illnesses 
since 1995 could be traced to the consumption of commercially 
harvested raw or undercooked oysters that originated from the state's 
waters. Initially, four states--Alabama, Florida, Louisiana, and 
Texas--exceeded that threshold and therefore, in accordance with the 
shellfish safety guidelines, were expected to develop such plans. 
[Footnote 2] The states' risk management plans relied primarily on 
consumer education aimed at high-risk (i.e., immune-compromised) 
individuals to reduce the rate of V. vulnificus illness and time and 
temperature controls to cool oysters to a specific temperature within 
a certain period after harvesting to reduce the growth of V. 
vulnificus. 

The shellfish safety guidelines also included goals for reducing the 
rate of illness for four reporting states[Footnote 3]--California, 
Florida, Louisiana, and Texas; for those states, the guidelines 
specified illness rate reduction goals of 40 percent by the end of 
2006 and 60 percent by the end of 2008.[Footnote 4] If the 60 percent 
goal was not achieved, the Gulf Coast states (Alabama, Florida, 
Louisiana, Mississippi, and Texas) were to implement one or more 
illness reduction strategies identified in the guidelines--postharvest 
processing methods (such as a mild heat treatment known as low 
temperature pasteurization) to reduce V. vulnificus to nondetectable 
levels, closing oyster harvest areas, or removing oysters from their 
shells (i.e., shucking) for cooking prior to consumption--or 
"equivalent" strategies. According to FDA and the ISSC, however, by 
the end of 2008, the four reporting states achieved about a 35 percent 
V. vulnificus illness rate reduction and therefore missed the 60 
percent goal by about 25 percent. Instead of imposing the illness 
reduction strategies specified in the guidelines if the illness rate 
reduction goals were not met, in May 2009, the ISSC approved, with FDA 
concurrence, new more stringent time and temperature controls. These 
controls were intended to help achieve the approximately 25 percent 
illness rate reduction needed to meet the 60 percent goal by the end 
of 2010. 

By October 2009, FDA announced its intent to change its approach to V. 
vulnificus illnesses from reducing them to largely eliminating them. 
Specifically, FDA said that, in spite of the ISSC's efforts, the 
number of V. vulnificus illnesses had not significantly declined and 
strategies that fall well short of eliminating V. vulnificus were no 
longer sufficient. FDA has also raised concerns with the current 
approach for measuring V. vulnificus illness reductions. Furthermore, 
in an October 2009 letter to the ISSC, FDA went on to say that 
academia, the oyster industry, and government, with the support of the 
ISSC, had developed postharvest processing technologies that could 
largely eliminate V. vulnificus illnesses and that the Gulf Coast 
oyster industry has the capacity to use postharvest processing on 100 
percent of Gulf Coast oysters intended for raw consumption. 

In your role during the 111th Congress as the Chairwoman of the House 
Appropriations Subcommittee on Agriculture, Rural Development, Food 
and Drug Administration, and Related Agencies, you asked us to review 
efforts of FDA and the ISSC to reduce illnesses caused by oysters 
contaminated with V. vulnificus bacteria. Accordingly, this report 
examines the extent to which (1) FDA and the ISSC are currently in 
agreement on a V. vulnificus illness reduction goal, (2) FDA and the 
ISSC use a credible approach to measure progress toward their V. 
vulnificus illness rate reduction goal, (3) FDA and the ISSC have 
evaluated the effectiveness of consumer education programs and time 
and temperature controls in reducing V. vulnificus consumption-related 
illnesses, and (4) the Gulf Coast oyster industry has adequate 
capacity to use postharvest processing on oysters harvested during 
warmer months and intended for raw consumption. 

To determine the extent to which FDA and the ISSC are in agreement on 
a V. vulnificus illness reduction goal, we reviewed the ISSC's meeting 
minutes and FDA's responses to ISSC proposals regarding illness 
reduction goals. To determine the extent to which FDA and the ISSC 
have used a credible approach to measure progress toward their V. 
vulnificus illness rate reduction goals, we analyzed the number of 
states used in determining V. vulnificus illness rate reduction, the 
effectiveness of primary V. vulnificus illness rate reduction 
strategies, and the effect of such factors as natural and manmade 
disasters on V. vulnificus illness rate reduction. To determine the 
extent to which FDA and the ISSC have evaluated the effectiveness of 
consumer education programs in reducing V. vulnificus consumption-
related illnesses, we reviewed relevant ISSC-commissioned surveys and 
studies and the V. vulnificus consumer education activities of 
Florida, Louisiana, and Texas. We also interviewed officials from 
these states' health agencies and members of the ISSC's Vibrio 
education committee. To determine the extent to which FDA and the ISSC 
have evaluated the effectiveness of time and temperature controls in 
reducing V. vulnificus consumption-related illnesses, we reviewed 
scientific literature and reports. We also analyzed the data in the 
model that was the basis for a tool that FDA developed for Florida, 
Louisiana, and Texas to use in determining their time and temperature 
controls. We also replicated the model to determine its validity and 
then modified it to simulate the impact of the time and temperature 
controls implemented by Florida, Louisiana, and Texas in May 2010 (see 
appendix I). In addition, we interviewed a nonprobability sample of 11 
leading Vibro researchers about the scientific underpinnings of time 
and temperature controls[Footnote 5] and law enforcement officials 
from agencies in Florida, Louisiana, and Texas regarding their time 
and temperature enforcement activities. To determine the extent to 
which there is adequate capacity to use postharvest processing on Gulf 
Coast oysters harvested during warmer months and intended for raw 
consumption, we analyzed the 2011 FDA-commissioned Research Triangle 
Institute International (RTI) report that addressed the feasibility 
and economic impacts of requiring postharvest processing.[Footnote 6] 
We also interviewed the lead author of the RTI report. To address all 
four objectives, we interviewed knowledgeable officials from FDA, the 
ISSC, and state regulatory agencies in Florida, Louisiana, and Texas, 
as well as representatives from the Gulf Coast oyster industry. We 
also conducted site visits to Florida, Louisiana, and Texas and 
attended key ISSC meetings in Alabama and Florida. 

We conducted this performance audit from May 2010 to September 2011 in 
accordance with generally accepted government auditing standards. 
Those standards require that we plan and perform the audit to obtain 
sufficient, appropriate evidence to provide a reasonable basis for our 
findings and conclusions based on our audit objectives. We believe 
that the evidence obtained provides a reasonable basis for our 
findings and conclusions based on our audit objectives. 

Background: 

Gulf Coast oysters are commercially harvested from the waters of the 
Gulf of Mexico adjacent to Alabama, Florida, Louisiana, Mississippi, 
and Texas and shipped throughout the United States. Figure 1 shows the 
Gulf Coast states and the location of the primary oyster harvest areas 
in the Gulf of Mexico. 

Figure 1: Gulf Coast States and Oyster Harvest Areas: 

[Refer to PDF for image: illustrated U.S. map] 

The map highlights the locations of oyster harvest areas in the states 
of Alabama, Florida, Louisiana; Mississippi, and Texas. 

Source: RTI. 

[End of figure] 

According to statistics from the Department of Commerce's National 
Oceanic and Atmospheric Administration (NOAA), in 2009, the Gulf Coast 
region produced about 23 million pounds of oysters, approximately 63 
percent of the nation's total domestic production, valued at about $72 
million. Figure 2 shows the amount and value of oysters harvested by 
Gulf Coast states in 2009, the most recent year for which these data 
are available. 

Figure 2: Amount and Value of Oysters Harvested by Gulf Coast States 
in 2009: 

[Refer to PDF for image: 2 vertical bar graphs] 

Amount harvested: 

State: Louisiana; 
Amount harvested: 14.7 million pounds. 

State: Texas; 
Amount harvested: 2.7 million pounds. 

State: Mississippi; 
Amount harvested: 2.2 million pounds. 

State: Florida (west coast); 
Amount harvested: 2.9 million pounds. 

State: Alabama; 
Amount harvested: 0.023 million pounds. 

Total Amount harvested: 23 million pounds. 

Value: 

State: Louisiana; 
Value: $50 million. 

State: Texas; 
Value: $9.4 million. 

State: Mississippi; 
Value: $6.1 million. 

State: Florida (west coast); 
Value: $6.9 million. 

State: Alabama; 
Value: $0.077 million. 

Total Value: $72 million. 

Source: NOAA. 

Note: The amounts and value of oysters harvested are rounded. 

[End of figure] 

Because V. vulnificus is more abundant in oysters harvested during the 
warmer-weather months (April through November), consumers who eat raw 
oysters harvested during this period are likely to be exposed to 
greater amounts of V. vulnificus. Although most healthy people do not 
become ill from V. vulnificus, people with certain medical conditions--
such as chronic liver disease, hemochromatosis,[Footnote 7] cancer, 
kidney disease, diabetes, and human immunodeficiency virus/acquired 
immune deficiency syndrome--are at risk of developing a potentially 
fatal bloodstream infection known as septicemia, which is 
characterized by fever and chills, life-threatening low blood 
pressure, and blistering skin lesions. Figure 3 shows that V. 
vulnificus consumption-related illnesses peak during April through 
November and remain quite low from December through March. 

Figure 3: Total Number of V. Vulnificus Oyster Consumption-Related 
Illnesses Reported Nationally, by month, from 2000-2010: 

[Refer to PDF for image: line graph] 

Illnesses peak during warmer months, May through October. 

Month: January; 
Number of reported illnesses: 0. 

Month: February; 
Number of reported illnesses: 3. 

Month: March; 
Number of reported illnesses: 4. 

Month: April; 
Number of reported illnesses: 38. 

Month: May; 
Number of reported illnesses: 33. 

Month: June; 
Number of reported illnesses: 42. 

Month: July; 
Number of reported illnesses: 58. 

Month: August; 
Number of reported illnesses: 68. 

Month: September; 
Number of reported illnesses: 41. 

Month: October; 
Number of reported illnesses: 38. 

Month: November; 
Number of reported illnesses: 40. 

Month: December; 
Number of reported illnesses: 2. 

Source: GAO analysis, including preliminary 2010 ISSC data. 

[End of figure] 

According to the ISSC's data, since 2000, 348 V. vulnificus 
consumption-related illnesses have been reported nationally. As figure 
4 shows, the number of V. vulnificus consumption-related illnesses 
reported nationally from 2000 to 2010 have been relatively consistent 
annually--with the exception of 2005 and 2010, when Hurricane Katrina 
and the Deepwater Horizon oil spill, respectively, severely reduced 
the oyster harvest. 

Figure 4: Number of V. Vulnificus Oyster Consumption-Related Illnesses 
Reported Nationally, by Year, from 2000-2010: 

[Refer to PDF for image: line graph] 

Calendar year: 2000; 
Number of yearly illnesses: 30. 

Calendar year: 2001; 
Number of yearly illnesses: 40. 

Calendar year: 2002; 
Number of yearly illnesses: 35. 

Calendar year: 2003; 
Number of yearly illnesses: 32. 

Calendar year: 2004; 
Number of yearly illnesses: 32. 

Calendar year: 2005[A]; 
Number of yearly illnesses: 13. 

Calendar year: 2006; 
Number of yearly illnesses: 39. 

Calendar year: 2007; 
Number of yearly illnesses: 34. 

Calendar year: 2008; 
Number of yearly illnesses: 30. 

Calendar year: 2009; 
Number of yearly illnesses: 40. 

Calendar year: 2010[B]; 
Number of yearly illnesses: 23. 

Source: GAO analysis, including preliminary 2010 ISSC data. 

[A] Hurricane Katrina struck the Gulf Coast region in August 2005, 
causing significant damage to the oyster industry. Oyster beds and 
vessels along the Gulf Coast were extensively damaged, if not 
destroyed, by siltation and contamination related to Hurricane Katrina. 

[B] The Deepwater Horizon oil spill in the Gulf of Mexico occurred in 
April 2010, causing significant damage to the oyster industry. The oil 
spill resulted in numerous harvest area closures and significant death 
of oysters from freshwater diversions that were used to prevent oil 
from reaching shorelines. 

[End of figure] 

Although the number of V. vulnificus consumption-related illnesses is 
small, the costs of the disease are high because of the high mortality 
rate--about 50 percent, according to CDC--costing the nation about 
$124 million annually, according to FDA. However, a senior ISSC 
official said FDA's estimate overstates the annual costs related to V. 
vulnificus consumption-related illnesses because it does not factor in 
the age and pre-existing health condition of the victims. 

As the federal agency responsible for ensuring the safety of 
shellfish, including oysters, in March 1984, FDA entered into a 
memorandum of understanding with the ISSC recognizing it as the 
primary voluntary national organization of state shellfish regulatory 
officials that provides guidance and counsel on matters related to the 
sanitary control of shellfish. The ISSC provides a formal structure 
for state regulatory authorities to establish guidelines, and 
procedures for applying those guidelines, for the sanitary control of 
the oyster industry. These guidelines must be reviewed by FDA for 
consistency with existing laws, regulations, and policies before they 
can be adopted. In addition to FDA and state regulatory officials, the 
ISSC also includes members from the shellfish industry and other 
federal agencies. 

Postharvest processing, closing oyster harvest areas, and shucking can 
all be expected to either substantially reduce or essentially 
eliminate exposure to V. vulnificus bacteria by consumers of raw 
oysters.[Footnote 8] However, when the 60 percent illness rate 
reduction goal was not met by the end of 2008, instead of implementing 
these strategies, FDA and the ISSC relied on estimates generated by 
FDA's V. vulnificus risk calculator in adopting time and temperature 
controls that they considered to be an equivalent strategy.[Footnote 
9] Senior FDA and ISSC officials told us that although time and 
temperature controls are not equivalent to the other strategies in the 
guidelines in terms of the total amount of illness reduction each can 
achieve, they considered the new time and temperature controls to be 
equivalent in that, according to the risk calculator's estimations, 
they would equivalently help the states to achieve the approximately 
25 percent illness rate reduction needed to meet the 60 percent goal 
by the end of 2010. Table 1 shows the time and temperature controls 
implemented in Florida, Louisiana, and Texas on May 1, 2010. 

Table 1: Time and Temperature Controls Implemented by Florida, 
Louisiana, and Texas Beginning May 1, 2010: 

State: Florida; 
Period controls were in effect: May through October; 
Maximum time from harvest to refrigeration (hours): 6[A]; 
Maximum time from refrigeration to internal oyster meat temperature of 
55°F (hours): 2[A]. 

State: Louisiana; 
Period controls were in effect: May through October; 
Maximum time from harvest to refrigeration (hours): 1; 
Maximum time from refrigeration to internal oyster meat temperature of 
55°F (hours): 6. 

State: Texas; 
Period controls were in effect: May and October; 
Maximum time from harvest to refrigeration (hours): 4; 
Maximum time from refrigeration to internal oyster meat temperature of 
55°F (hours): 6. 

State: Texas; 
Period controls were in effect: June and September; 
Maximum time from harvest to refrigeration (hours): 3; 
Maximum time from refrigeration to internal oyster meat temperature of 
55°F (hours): 6. 

State: Texas; 
Period controls were in effect: July and August; 
Maximum time from harvest to refrigeration (hours): 1; 
Maximum time from refrigeration to internal oyster meat temperature of 
55°F (hours): 6. 

Source: GAO analysis of Florida, Louisiana, and Texas 2010 V. 
vulnificus risk management plans. 

[A] This is the rapid cooling control option, one of four time and 
temperature control options authorized in Florida's V. vulnificus risk 
management plan and the only option used during the summer of 2010 by 
the Florida oyster industry, according to a senior Florida regulatory 
official. 

[End of table] 

Although FDA had concurred with the use of new time and temperature 
controls earlier in 2009, in October of that year, a senior FDA 
official stated that the agency would require postharvest processing 
to reduce V. vulnificus to nondetectable levels. There are currently 
four methods for processing oysters after they have been harvested to 
reduce V. vulnificus to nondetectable levels: (1) high-pressure 
processing, (2) a mild heat treatment known as cool pasteurization, 
(3) cryogenic quick freezing, and (4) irradiation. Each of these 
processes--except irradiation--is currently in limited, voluntary 
commercial use in the Gulf Coast region. The senior FDA official 
indicated that the postharvest processing requirement would apply to 
all Gulf Coast oysters harvested during the warmer months of the year 
beginning with the 2011 harvest season. However, in response to 
concerns expressed by some members of Congress and the ISSC, among 
others, FDA suspended its plan to require postharvest processing until 
a study was done to determine how postharvest processing can be 
implemented in the fastest, safest, and most economical way. In 2010, 
FDA contracted with RTI to study the feasibility and economic impacts 
of requiring postharvest processing of Gulf state (Alabama, Florida 
Louisiana, Mississippi, and Texas) oysters harvested from April 
through October and intended for raw consumption.[Footnote 10] 

FDA and the ISSC Do Not Currently Agree on a V. Vulnificus Illness 
Reduction Goal: 

In October 2009, a senior FDA official announced in a speech before 
the ISSC that, under FDA's Hazard Analysis and Critical Control Point 
rules, beginning in May 2011, FDA intended to require postharvest 
processing of all Gulf Coast oysters harvested during warmer months, 
when higher levels of V. vulnificus are more likely to be present, to 
reduce V. vulnificus to nondetectable levels.[Footnote 11] 

According to FDA officials, the agency took this action for two 
primary reasons. First, consumer education activities and time and 
temperature controls, which had been in use by Louisiana, Florida, and 
Texas since 2001, had not achieved the 60 percent goal by the 2008 
deadline.[Footnote 12] Second, validated methods of postharvest 
processing technology had become available. FDA noted that in 
California, since the state began requiring postharvest processing of 
Gulf Coast oysters in 2003, there had been zero consumption-related V. 
vulnificus illnesses. A senior FDA official said FDA now believes that 
postharvest processing of oysters is the control measure that best 
meets the intent of its Hazard Analysis and Critical Control Point 
seafood safety requirement to prevent, eliminate, or reduce to an 
acceptable level the occurrence of pathogens such as V. vulnificus. 

In a November 2009 letter to FDA, the ISSC expressed disappointment 
that FDA had unilaterally decided to announce its intent to change its 
policy and had not followed the 1984 memorandum of understanding that 
calls for FDA and the ISSC to exchange information concerning the 
shellfish safety program and resolve problems of interpretation and 
policy. According to the letter, the ISSC was concerned that FDA was 
now proposing to abandon the V. vulnificus risk management plans 
adopted in 2001 by the ISSC with FDA concurrence. Furthermore, the 
ISSC, with FDA's concurrence, had already agreed to implement new time 
and temperature controls to address V. vulnificus beginning in May 
2010. The ISSC letter also stated that if FDA continued its effort 
without ISSC support, it was likely that many Gulf Coast states would 
choose not to exercise their enforcement responsibilities under the 
shellfish safety program with regard to postharvest processing, and 
instead might implement intrastate programs that could allow 
consumption of raw oysters produced within their state without the 
controls necessary to substantially reduce V. vulnificus illnesses. In 
its April 2010 response to the ISSC, FDA acknowledged the ISSC's 
concerns and agreed to work collaboratively with it to identify the 
steps needed before implementing a postharvest processing requirement 
for Gulf Coast oysters harvested during the warmer months. 
Specifically, FDA agreed to fund an independent study, which RTI later 
conducted, to assess how postharvest processing and equivalent 
controls could be implemented in the fastest, safest, and most 
economical way. 

Nevertheless, FDA and the ISSC have not yet agreed on a new illness 
reduction goal and the strategies for achieving that goal. As we noted 
in our October 2005 report on practices that can help agencies enhance 
and sustain collaboration, agencies need to define and articulate the 
common outcome they are seeking to achieve that is consistent with 
their respective agency goals and missions.[Footnote 13] Also, to 
achieve the common outcome, collaborating agencies need to establish 
strategies that work in concert with those of their partners or are 
joint in nature. Furthermore, trust is a necessary element for a 
collaborative relationship and it is critical to involve all key 
stakeholders in decision-making. In summary, our October 2005 report 
indicates that absent effective collaboration, it is unlikely that 
agencies can develop and implement joint agreements. If FDA and the 
ISSC cannot agree on the V. vulnificus illness reduction goal and 
strategies to achieve the goal, it is unlikely that the states' 
efforts to significantly reduce the number of consumption-related V. 
vulnificus illnesses will be effective. 

The Approach FDA and the ISSC Use for Measuring Progress toward Their 
Illness Rate Reduction Goal Has Limitations That Undermine Its 
Credibility: 

The approach FDA and the ISSC have been using to measure progress 
toward their 60 percent illness rate reduction goal established in 
2001 has three main limitations that undermine its credibility: the 
limited number of states used in determining V. vulnificus illness 
reduction, overstatement of the effectiveness of the primary V. 
vulnificus illness reduction strategies, and not controlling for the 
effect of such factors as natural and man-made disasters. 

Limited number of states used in determining V. vulnificus illness 
rate reduction. First, the approach FDA and the ISSC use for measuring 
progress toward their illness rate reduction goal is based on the 
inclusion of V. vulnificus illness data from four states: California, 
Florida, Texas, and Louisiana. V. vulnificus illnesses related to raw 
oyster consumption occur in other states, but the FDA and ISSC 
measurement approach does not capture either the scope of such 
illnesses from oysters harvested from the entire Gulf Coast region or 
the national scope of V. vulnificus illnesses. According to a senior 
ISSC official, the ISSC selected the four states because of the 
quality of their illness reporting systems since each had been 
consistently reporting V. vulnificus illnesses for the longest time 
period and because most other states were not reporting V. vulnificus 
illnesses. Since 2007, annually, about 20 states have reported V. 
vulnificus illnesses to CDC. Senior FDA officials told us they advised 
the ISSC to begin including more states in the V. vulnificus illness 
calculation to better reflect the occurrence of V. vulnificus 
illnesses nationally. According to FDA officials, the ISSC has not 
responded to their recommendation. A senior ISSC official acknowledged 
to us that analyzing national data would provide a more representative 
measure of progress toward the illness rate reduction goal than the 
current approach. The official told us that the ISSC is meeting in 
October 2011 to discuss, among other things, developing an alternative 
approach to measuring progress toward the illness rate reduction goal. 

Overstatement of the effectiveness of primary V. vulnificus illness 
rate reduction strategies. In addition to not reflecting the national 
scope of V. vulnificus illnesses, the FDA and ISSC approach overstates 
the effectiveness of their primary V. vulnificus illness rate 
reduction strategies--consumer education and time and temperature 
controls--by including V. vulnificus illness data from California. 
Since 2003, California has required postharvest processing of all raw 
Gulf Coast oysters harvested from April through October and sold in 
the state and has reported two consumption-related V. vulnificus 
illnesses since the requirement took effect. A senior ISSC official 
acknowledged that California's postharvest processing requirement has 
reduced the number of V. vulnificus illnesses in that state. This 
official also acknowledged that including California's results 
contributed significantly to achieving the interim 2006 40 percent 
illness rate reduction goal. For this reason, both California and FDA 
officials have requested that the ISSC no longer include California 
data in its illness rate reduction calculation. According to a senior 
ISSC official, however, California data should be included because 
reporting states should not be excluded based on the states' chosen V. 
vulnificus illness rate reduction strategies. 

Lack of control for the effect of such factors as natural and man-made 
disasters. The FDA and ISSC measurement approach does not control for 
the effect of such factors as natural and manmade disasters. FDA, 
ISSC, and state officials we spoke with agree that the level of V. 
vulnificus illnesses is associated with the level of oyster production 
and consumption. When oyster production decreases as a result of 
factors such as natural or man-made disasters like Hurricane Katrina 
in 2005 and the Deepwater Horizon oil spill in 2010, the level of 
oyster consumption also decreases and, with it, the rate of V. 
vulnificus illnesses. Not controlling for the effect of factors 
external to the V. vulnificus illness rate reduction strategies chosen 
by FDA and the ISSC gives a misleading indication of the success of 
those strategies. In 2000, the ISSC considered a proposal to calculate 
illness rate as the number of illnesses divided by oyster production. 
According to a senior ISSC official, the ISSC did not approve the 
proposal because oyster production data were not readily available, 
which is no longer the case. After rejecting the 2000 proposal to 
account for production, in 2001 the ISSC adopted a proposal to 
calculate the illness rate as the number of illnesses per unit of 
population. A senior FDA official told us that FDA initially agreed 
with this proposal because illnesses per unit of population is a 
standard measure used by CDC for tracking the prevalence of many 
illnesses. In retrospect, however, FDA and ISSC officials told us that 
population should not be part of the calculation. A senior FDA 
official explained that tracking illnesses per unit of population is 
meaningful for certain types of illnesses but is not meaningful for 
others. For example, he told us that tracking illnesses per unit of 
population makes sense for illnesses that are passed from person-to-
person or for food-borne illnesses associated with foods that are 
widely consumed but that it does not make sense for illnesses 
associated with foods like oysters, which are a specialty food and not 
widely consumed throughout the population. 

In 2009, the ISSC adopted a proposal to change its measure of 
effectiveness from illness rate reduction to risk reduction, which 
would be based on the risk per serving of raw or undercooked oysters. 
Under the proposal, the revised goal would be to reduce the risk per 
serving to a level equivalent to the current 60 percent illness rate 
reduction goal. FDA initially opposed the proposal but later 
concurred, stating that the change would eliminate the problems 
associated with the current approach for measuring V. vulnificus 
illness rate reduction. In March 2010, the ISSC appointed a workgroup 
to explore implementation of the proposal. According to a senior ISSC 
official, as of March 2011, the work group had held one conference 
call but had not yet determined how the concept of risk per serving 
would be applied and measured in the V. vulnificus illness context. 
According to the ISSC official, the proposal is scheduled to be 
implemented in January 2012. 

FDA and the ISSC Have Taken Few Steps to Evaluate the Effectiveness of 
Consumer Education and Time and Temperature Controls: 

FDA and the ISSC have performed either very limited or no evaluations 
of the effectiveness of their key V. vulnificus illness reduction 
strategies. Specifically, the ISSC has not evaluated the effectiveness 
of consumer education efforts in reducing V. vulnificus illnesses 
since 2004, and FDA has not conducted any evaluations of its own. In 
addition, although the V. vulnificus risk calculator developed by FDA 
estimates that time and temperature controls can reduce V. vulnificus 
illnesses, FDA and the ISSC have not directly evaluated the 
effectiveness of the May 2010 time and temperature controls that the 
ISSC approved, with FDA concurrence, for the states to use in reducing 
consumption-related V. vulnificus illnesses. 

The ISSC Has Not Evaluated the Effectiveness of Consumer Education 
Efforts Since 2004, and FDA Has Not Conducted Its Own Evaluations: 

The ISSC conducted consumer surveys in 2002 and 2004 that were 
intended to measure the extent to which (1) V. vulnificus education 
programs increased consumer awareness of the risks of eating raw 
oysters and (2) high-risk consumers refrained from eating raw oysters 
for health reasons. The 2002 survey of raw oyster consumers 
established baseline information on consumers' beliefs about raw 
oysters, consumption patterns, and knowledge of risks associated with 
eating Gulf Coast raw oysters. The 2004 follow-up survey measured 
whether raw oyster consumers changed their raw oyster consumption 
patterns during the previous 2 years as a result of the ISSC's and 
states' (Florida, Louisiana, and Texas) V. vulnificus consumer 
education efforts. The 2004 survey found no significant increase in 
overall consumer knowledge about the risk of eating raw oysters or the 
proportion of high-risk consumers who stopped eating them. 

A senior FDA official said that the agency has not conducted its own 
evaluation of the effectiveness of V. vulnificus consumer education 
efforts; instead it relied on the ISSC's surveys to determine the 
impacts of consumer education efforts. FDA officials told us that 
their review of consumer education efforts is limited to checking the 
V. vulnificus risk management plans implemented by Florida, Louisiana, 
and Texas to ensure the plans include a consumer education component. 
According to FDA and state officials, the states' V. vulnificus 
education efforts have included a variety of activities such as online 
V. vulnificus education courses for physicians, nurses, and 
dieticians; public service announcements for broadcast on television 
and radio; advisories included with the drug prescriptions of high-
risk consumers; and brochures targeting high-risk consumers that 
contained information about the risk of eating raw oysters. FDA and 
ISSC officials stated that although they have not directly evaluated 
the states' education efforts since 2004, their indirect measure of 
the effectiveness of consumer education was whether they achieved 
their 2008 60 percent illness rate reduction goal. They acknowledged, 
however, that the goal was not achieved, and, therefore, presumably 
consumer education alone would not achieve the goal. 

Some state officials told us that it is very difficult to measure and 
evaluate the direct impact that consumer education has on a relatively 
rare event, such as V. vulnificus illness. One state official said 
that his state did not have the expertise and financial resources to 
conduct an evaluation of the effectiveness of its consumer education 
programs. The same official added that it would be difficult to prove 
that a specific case of V. vulnificus was prevented because of 
consumer education efforts. 

An ISSC official said that some members of the ISSC have concluded 
that consumer education is not going to result in a significant 
reduction in V. vulnificus illnesses. For example, one state official 
said that the effectiveness of education is hampered by the fact that 
some of those who are most vulnerable to V. vulnificus illness, such 
as alcoholics with liver disease, are risk takers who refuse to change 
their raw oyster consumption habits. 

In our September 2005 report on managing for results, we noted that 
federal agencies should regularly measure the effectiveness of their 
programs to determine whether progress is being made toward 
performance goals.[Footnote 14] Specifically, agencies should compare 
their programs' results against their goals and determine where to 
target program resources to improve performance. We recognize that it 
is difficult to assess the effectiveness of consumer education 
programs. Nonetheless, the absence of information on the effectiveness 
of V. vulnificus consumer education programs limits the ability of the 
ISSC and the states to identify and increase the use of consumer 
education approaches that are working well and discontinue those that 
have not been effective. Furthermore, without regular evaluations of 
the effectiveness of consumer education, ISSC and state officials 
cannot ensure that their resources are targeted strategically and are 
not wasted on efforts that are ineffective. 

FDA and the ISSC Have Not Directly Evaluated the Effectiveness of Time 
and Temperature Controls in Reducing V. Vulnificus Consumption-Related 
Illnesses: 

Neither FDA nor the ISSC has directly evaluated the effectiveness of 
the new time and temperature controls in reducing V. vulnificus 
illnesses since they were implemented in May 2010. Instead, FDA and 
the ISSC have relied on illness rate reduction as the overall measure 
of effectiveness of all V. vulnificus illness reduction strategies 
combined. Both FDA and ISSC officials acknowledge, however, that doing 
so does not distinguish the effect of time and temperature controls 
from that of other factors. Consequently, illness rate reduction does 
not provide a direct indication of the effectiveness of the time and 
temperature controls, implemented and enforced by the states, in 
contributing to V. vulnificus illness reduction. 

Senior FDA and ISSC officials told us that one way to more directly 
evaluate the effectiveness of time and temperature controls is to 
conduct studies to determine the level of V. vulnificus bacteria in 
oysters prior to and following implementation of the 
controls.[Footnote 15] FDA officials told us that such studies were 
conducted in 1998-1999 and 2007, prior to the implementation of the 
new time and temperature controls.[Footnote 16] Those studies surveyed 
the level of V. vulnificus bacteria and other pathogens in oysters 
collected from both retail and wholesale establishments.[Footnote 17] 
The level of V. vulnificus bacteria found in 2007 was similar to that 
found in 1998-1999. According to the 2007 study, the similarity was 
not surprising given that time and temperature controls had not 
changed since the 1998-1999 study and that the ISSC's efforts to 
reduce V. vulnificus illnesses had focused on educating high-risk 
consumers. FDA officials told us that data from those studies could be 
compared against future study data to measure the effectiveness of new 
controls, including time and temperature controls, aimed at reducing 
exposure to V. vulnificus bacteria by consumers of raw oysters. A 
senior ISSC official told us that he intends to promote the use of 
such studies to evaluate time and temperature control effectiveness. 
FDA officials told us that, although they would like to repeat the 
1998-1999 and 2007 studies, FDA has no plans to do so given the 
expense of the studies, competing priorities, and resource constraints. 

To estimate the level of V. vulnificus illness rate reduction states 
might expect to achieve from time and temperature controls, FDA and 
the ISSC have relied on FDA's V. vulnificus risk calculator. Estimates 
generated by the risk calculator indicated that the new time and 
temperature controls implemented in May 2010 would help the states to 
achieve the 60 percent illness rate reduction goal by the end of 2010. 
To achieve the calculator's estimated illness rate reduction, oyster 
industry members would have to fully comply with the time and 
temperature controls. Our discussions with FDA, state officials, and 
oyster industry representatives, however, suggest that while data 
regarding compliance levels are unavailable, full compliance is highly 
unlikely. In January 2011 FDA and the ISSC determined the goal still 
had not been met. 

To assess the precision of the risk calculator's estimates, we 
replicated and modified a risk simulation model--developed by the 
World Health Organization and the Food and Agriculture Organization 
(WHO/FAO) of the United Nations in partnership with FDA--that FDA used 
as a basis for developing the risk calculator. Our analysis indicates 
that even with 100 percent compliance, the risk of V. vulnificus 
illness under time and temperature controls may differ from the number 
estimated by the risk calculator. For example, in Texas in the month 
of August, FDA's risk calculator estimates that time and temperature 
controls will lead to 2.84 illnesses per 100,000 raw oyster servings. 
While this is accurate on average, the number of illnesses per 100,000 
servings could be as low as 2.44 or as high as 3.63 (for a 90 percent 
uncertainty interval), according to our analysis. We find a similar 
range of uncertainty in the estimated number of V. vulnificus 
illnesses for Florida and Louisiana. See appendix I for more details 
about our analysis. While uncertainty is an inherent part of estimates 
produced by all quantitative models, the risk calculator does not 
report the amount of uncertainty associated with its estimates. 

Extent of Industry Compliance with Time and Temperature Controls Is 
Unknown: 

Although under the shellfish safety guidelines, states are responsible 
for enforcing oyster industry compliance with time and temperature 
controls, senior officials in Florida, Louisiana, and Texas told us 
they do not track compliance rates. A senior ISSC official confirmed 
that these states do not systematically collect, analyze, and report 
compliance information. Enforcement consists largely of periodic state 
inspections of oyster-processing plants and on-the-water harvester 
activities. The latter includes checking log sheets on which 
harvesters record whether they are harvesting oysters for raw 
consumption and, if so, whether they are complying with various 
elements of the time and temperature controls. Enforcement personnel 
in Louisiana, Florida, and Texas told us they do not inspect all 
harvesting vessels and do not verify the accuracy of all of the 
information recorded by the harvesters whose vessels they do inspect. 
For example, a Louisiana official told us that Louisiana enforcement 
personnel are to check the log sheet to ensure the harvester has 
recorded the time harvesting began but has no way of verifying whether 
the information is accurate. Figure 5 shows a sample log sheet used in 
Louisiana. 

Figure 5: Sample Log Sheet: 

[Refer to PDF for image: illustration] 

Harvester-Dealer Time/temperature: 
Log Sheet: 

Harvester Information: 

Boat Name/number:
Harvester Name/License Number:
Harvester Signature:
Date: 

Molluscan Shellfish Harvested For Other Than Raw (Half Shell)
Consumption: 

Harvesting Area/lease No.:
Product Intended For Other Than Raw Consumption: Circle One: 
Bedding; 
Shucking; 
Relaying; 
Other (Explain): 

Time Harvesting Begins:
Time Harvesting Ends:
Number Of Sacks Of Oysters Harvested: 

Molluscan Shellfish Harvested For Raw (Half Shell) Consumption: 

Harvesting Area/lease No.:
Time Harvesting Begins:
Number Of Sacks Of Oysters Harvested: 

Certified Dealer Information: 

Temperature Of Cooler When Unloading Oysters Begins: 
Time When Last Oyster From Boat Are Placed In Cooler:
Temperature Of Cooler When Last Oysters From The Boat Are Placed In 
Cooler: 

Original Certified Dealer Signature (Or Authorized Representative): 
Date: 

Source: Louisiana Administrative Code, Title 51, Part IX, Chapter 3, 
Section 345. 

[End of figure] 

FDA is responsible for evaluating states' enforcement of time and 
temperature controls. However, FDA officials told us that FDA's 
evaluations do not include assessments of the degree to which states 
are ensuring industry compliance. Instead, FDA officials told us their 
evaluations consist of checking states' V. vulnificus risk management 
plans to ensure the plans include the time and temperature controls 
outlined in the shellfish safety guidelines, accompanying state 
officials on selected oyster-processing-plant inspections and on-the- 
water patrols, and reviewing selected shellfish safety plans and 
records. 

A senior ISSC official told us the ISSC planned to evaluate the 
effectiveness of the new time and temperature controls, in part, based 
on the rate of oyster industry compliance and the level of states' 
enforcement. However, because FDA, the ISSC, and states did not 
collect any industry compliance or state enforcement data, when it 
came time to conduct the evaluation in January 2011, the ISSC had to 
rely on testimonial evidence from state officials regarding the extent 
of industry compliance and state enforcement. 

Although data are unavailable regarding oyster industry compliance 
with time and temperature controls, our discussions with state 
officials and oyster industry members suggest full compliance is 
highly unlikely. During several discussions with state officials and 
oyster industry members, we were told of instances of intentional 
mislabeling, a form of seafood fraud.[Footnote 18] For example, 
harvesters initially labeled oysters harvested without meeting the new 
time and temperature controls for shucking or postharvest processing 
only but later mislabeled them for raw consumption. Figure 6 shows 
sample labels for oysters to be consumed raw and for oysters to be 
shucked or postharvest processed. 

Figure 6: Sample Oyster Labels: 

[Refer to PDF for image: illustration] 

Oyster label: green label; 
Description: Green labels are to be attached to sacks of oysters that 
have been harvested without meeting time and temperature controls and 
that should not, therefore, be consumed raw and instead must be 
shucked or postharvest processed. 

Oyster label: Blue label; 
Description: Blue labels are to be attached to sacks of oysters that 
have been harvested without meeting time and temperature controls but 
have been postharvest processed to reduce V. vulnificus bacteria to 
nondetectable levels. 

Oyster label: White label; 
Description: White labels are to be attached to sacks of oysters that 
have been harvested in compliance with time and temperature controls 
and may be consumed raw. 

Source: Louisiana Department of Wildlife and Fisheries. 

[End of figure] 

According to two large oyster processors we spoke with operating in 
both Louisiana and Texas, mislabeling is widespread and is driven by a 
considerable financial incentive to avoid the costs of complying with 
the time and temperature controls and obtain the higher price accorded 
raw oysters. A senior Florida regulatory official told us that 
mislabeling was identified during a recent routine inspection of a 
local oyster-processing plant and that he was aware of several 
occasions where oysters were served raw that should have been shucked 
or postharvest processed because they had not been harvested in 
compliance with the time and temperature controls. In July 2010, the 
ISSC sent a letter to member states informing them of deaths traced to 
raw consumption of oysters that should have been shucked or 
postharvest processed and requesting immediate action to ensure 
accurate labeling. According to a senior Louisiana law enforcement 
official, however, mislabeling is an easy practice to engage in and is 
very difficult for regulatory and law enforcement personnel to detect. 
During a January 2011 ISSC meeting, ISSC members acknowledged that 
compliance with the time and temperature controls was not as good as 
it should be. According to the meeting minutes, there have been 
numerous complaints from oyster processors regarding instances of 
noncompliance in Florida. At the January 2011 meeting, the ISSC passed 
a motion encouraging increased enforcement of the time and temperature 
controls by the Gulf Coast states. As of March 2011, however, the ISSC 
was unable to tell us what specifically they meant by increased 
enforcement or how the states planned to implement the motion. A 
senior FDA official told us that this motion is unlikely to be 
implemented in any meaningful way given limited state enforcement 
capacity. 

Extent of Illness Reduction from Time and Temperature Controls Depends 
on Compliance Levels: 

Given that compliance data are unavailable and that compliance rates 
are likely to be less than 100 percent, according to FDA, state 
officials, and oyster industry representatives, we used our 
modification of the WHO/FAO risk simulation model to estimate the 
effect of the compliance rate on the effectiveness of time and 
temperature controls in reducing V. vulnificus illness. Specifically, 
we estimated the number of illnesses during the summer months under 
the baseline scenario--in which the new more stringent 2010 time and 
temperature controls were not in effect--and under scenarios that 
assumed various levels of compliance with the new time and temperature 
controls. Our estimates show that the extent to which the new time and 
temperature controls would reduce V. vulnificus illnesses varies 
considerably with the level of compliance. For example, during a 
typical August month in Louisiana, assuming that 100 percent of 
oysters are harvested in compliance with time and temperature 
controls, the risk calculator estimates the controls will reduce 
illnesses by 41 percent on average, and our analysis estimates that 
illness reduction could range from 30 percent to 47 percent.[Footnote 
19] As shown in figure 7, at lower levels of compliance, the illness 
reduction would be considerably smaller. If 80 percent of the oysters 
are harvested in compliance with these controls--meaning that 20 
percent would be harvested out of compliance--we estimate that time 
and temperature controls would reduce illnesses by 15 percent to 23 
percent. As a result, even assuming 80 percent compliance in the 
summer months, it is unlikely that these controls will lead to the 
level of illness reduction estimated by the risk calculator. We found 
that noncompliance would have a similar effect in the other summer 
months and in the other states. See appendix I for details. 

Figure 7: Estimated Reduction in the Number of V. Vulnificus Illnesses 
as a Result of Time and Temperature Controls for Louisiana in August: 

[Refer to PDF for image: line graph] 

Percentage reduction in number of illnesses from baseline: 

Risk calculator estimate: 41%. 

Estimated compliance rate: 70%; 
Upper bound: 17%; 
Lower bound: 11%; 
Mean: 14%. 

Estimated compliance rate: 80%; 
Upper bound: 23%; 
Lower bound: 15%; 
Mean: 19%. 

Estimated compliance rate: 90%; 
Upper bound: 32%; 
Lower bound: 21%; 
Mean: 26%. 

Estimated compliance rate: 100%; 
Upper bound: 47%; 
Lower bound: 30%; 
Mean: 38%. 

Source: GAO. 

[End of figure] 

Adequate Capacity Does Not Exist to Use Postharvest Processing on Gulf 
Coast Oysters, and Questions Exist about the Feasibility of Developing 
Such Capacity: 

According to a March 2011 FDA-commissioned report by RTI, the Gulf 
Coast oyster industry does not currently have adequate capacity to use 
postharvest processing on all Gulf Coast oysters intended for raw 
consumption that are harvested during warmer months.[Footnote 20] The 
report found that two key issues need to be addressed to develop 
adequate capacity, including the construction of several central 
postharvest processing facilities. The report concluded that it would 
take at a minimum 2 to 3 years to develop the necessary capacity. 
[Footnote 21] However, we identified six issues of concern regarding 
the RTI report's economic analysis that call into question the 
completeness of its cost and timeline estimates. 

RTI Report Finds Adequate Capacity Does Not Exist for Postharvest 
Processing without Additional or Expanded Facilities: 

In October 2009, FDA announced its intent to begin requiring 
postharvest processing, in part, because it believed that adequate 
capacity existed. RTI's March 2011 FDA-commissioned report, however, 
found that adequate capacity does not exist and identified two key 
issues that must be addressed to ensure such capacity. First, about 
five or six central postharvest processing facilities would be needed 
to accommodate smaller Gulf Coast oyster processors that may be unable 
to conduct postharvest processing at their current facilities due to 
various limitations. For example, these smaller facilities generally 
lack sufficient floor space for installing postharvest processing 
equipment without undergoing costly plant expansion, and their owners 
may lack the financial resources to expand their plants and purchase 
postharvest processing equipment. In addition, the report described 
several necessary steps in developing the central facilities, 
including: (1) determining the legal and operating structure of the 
facilities, (2) identifying the property where the newly constructed 
facilities are to be located or existing buildings are to be modified, 
and (3) securing the financing for developing the facilities. While 
central facilities may allow some smaller oyster processors access to 
postharvest processing facilities during the warmer months, other 
challenges remain, such as the additional costs to transport oysters-- 
refrigerated--to and from the central facilities. 

Second, technical and financial assistance to several processing 
facilities would be needed to expand or alter their existing 
facilities, and purchase and install additional postharvest processing 
equipment. Again, the report describes several steps that must occur 
before initiating the expansion of existing facilities, such as 
developing plans for expanding the plant or altering the plant layout, 
and securing financing for purchasing additional equipment and 
constructing the expanded facility. Overall, the RTI report concluded 
that it will take a minimum of 2 to 3 years and, depending on the 
postharvest processing method used, about $6 million to $32 million in 
initial investment costs (excluding land purchase and construction 
costs for new centralized facilities) to develop the infrastructure 
required to ensure the Gulf Coast oyster industry has adequate 
capacity to use postharvest processing on all Gulf Coast oysters 
intended for raw consumption that are harvested during warmer months. 

In our July 2001 report on shellfish safety, we raised the concern 
that if the 60 percent V. vulnificus illness rate reduction goal was 
not achieved by 2008, postharvest processing capacity may not be 
available because the ISSC did not have a detailed plan for ensuring 
such capacity.[Footnote 22] Consequently, we recommended that FDA work 
with the ISSC to prepare and implement a detailed plan for developing 
adequate postharvest processing capacity to help achieve the ISSC's V. 
vulnificus illness rate reduction goals. In its response, FDA agreed 
with our recommendation, and the ISSC agreed that it did not have a 
detailed plan to ensure postharvest processing capacity. At that time, 
ISSC officials said that the matter was a high priority and would be 
addressed at its upcoming July 2001 meeting. At the July 2001 meeting, 
the ISSC proposed that the V. vulnificus risk management plans include 
a process for implementing a required postharvest treatment capacity 
for 50 percent of all oysters intended for the raw consumption market--
during the months of May through September--should the 40 percent 
illness reduction goal not be achieved by December 31, 2006. 

In 2003, the ISSC surveyed oyster dealers with postharvest processing 
capabilities in Florida, Louisiana, and Texas and found that there was 
sufficient capacity to use postharvest processing on 100 percent of 
the oysters harvested from May through September that were intended 
for raw consumption. According to FDA officials, until January 2011, 
when RTI presented its preliminary results, they believed there was 
sufficient capacity to use postharvest processing on all Gulf Coast 
oysters harvested from May through September. However, according to an 
ISSC official, the 2003 survey had major limitations such as quick 
freezing as a postharvest processing option, not considering the 
location of existing postharvest processing facilities, and not 
addressing whether existing facilities would treat their competitors' 
oysters. The RTI report indicated that quick freezing is not 
appropriate for oysters harvested in warmer months because this option 
substantially reduces their quality. The ISSC official said that in 
hindsight, FDA and the ISSC did not adequately define capacity in 2001 
when they began to discuss postharvest processing capacity goals. 

Six Issues of Concern Raise Questions about the Feasibility of 
Developing Adequate Postharvest Processing Capacity: 

FDA stated in October 2009 that postharvest processing should be 
required beginning in May 2011, in part, because it believed that 
adequate capacity existed. When the ISSC raised concerns, FDA tasked 
RTI with analyzing the feasibility and economic impacts of such a 
requirement. Although we believe that the overall method RTI used for 
its analysis is credible, its conclusion--that postharvest processing 
capacity to treat all Gulf Coast oysters intended for raw consumption 
that are harvested from April through October can be developed in a 
minimum of 2 to 3 years--is questionable due to six issues of concern 
we identified in RTI's economic analysis. We recognize that some of 
the issues we identified are the result of constraints faced by RTI, 
such as not being within the scope of the FDA-approved RTI report work 
plan, a lack of data, and the associated contractual report due dates 
(i.e., FDA needed the report completed before the 2011 summer oyster 
harvest season to help inform policy decisions). The six issues of 
concern are as follows. 

* Baseline data may not be representative of the industry. The RTI 
report relied on 2008 data--such as oyster harvest volumes, oyster 
prices, and the number of Gulf Coast oyster processors--as a 
representative baseline to estimate economic impacts of a postharvest 
processing requirement. We believe the 2008 data are not necessarily 
representative of the current state of the Gulf Coast oyster industry 
due to the events that occurred in 2010--the Deepwater Horizon oil 
spill and the implementation, on May 1, 2010, of the new, more 
stringent time and temperature controls. The lead author of the RTI 
report explained that using the 2008 data as a baseline was 
appropriate because 2008 was the most recent and complete year of 
data. Furthermore, the lead author said that it could take several 
years for the oyster industry to adjust to the 2010 events and that 
waiting for this adjustment to occur would not necessarily change the 
overall report's conclusions regarding the economic impacts of 
postharvest processing. However, the lead author acknowledged that 
using 2008 data was a limitation of the study and that using a 
baseline after the 2010 events would allow for more refined estimates. 
We believe the estimates in the report may be of limited use for 
determining how the market would respond to a postharvest processing 
requirement because the estimates are premised on the oyster 
industry's structure prior to the 2010 oil spill and implementation of 
the new time and temperature controls, which may not reflect the Gulf 
Coast oyster industry of the future. For example, oyster production 
was severely curtailed in 2010 compared with the baseline production 
in 2008. According to the Louisiana Department of Wildlife and 
Fisheries, the Louisiana oyster harvest was down by 50 percent in 
2010. Given the baseline used, the results of the economic impact 
analysis may not provide a valid basis for the oyster-processing 
industry to make investment decisions if a postharvest processing 
requirement is implemented. 

* Key costs are excluded. Certain key costs are excluded from the 
report's economic analysis. For example, the report does not include 
information on costs associated with purchasing land needed to expand 
existing postharvest processing facilities or construct new 
centralized facilities. The lead author of the RTI report said that 
land costs vary significantly by location. According to the lead 
author, a detailed analysis of such costs was not within the scope of 
the FDA-approved RTI report work plan. Although we agree that such 
costs are highly variable across regions, we believe that including a 
mean or median land cost would be better than omitting land costs 
altogether, as such costs may account for a large portion of the total 
costs to expand existing or construct new facilities. In addition, 
other significant costs are excluded from the economic analysis, such 
as construction costs for the new centralized facilities, insurance 
coverage for additional processing plant space and postharvest 
processing equipment, and costs for transporting oysters to and from 
the central postharvest processing facilities. The report acknowledges 
that insurance coverage may be a significant expense, especially in 
areas prone to severe weather and flooding. Furthermore, according to 
the report, processors will incur transportation costs if they are 
unable to install processing equipment at their facilities and instead 
have to rely on centralized facilities. Transportation costs would 
include either paying for trucking services or purchasing and 
operating a refrigerated truck. According to the lead author, these 
costs were not included because a detailed analysis of such costs was 
not within the scope of the FDA-approved report work plan. If key 
costs are not analyzed and included in the cost estimates, the full 
scope of the financial resources needed to ensure the Gulf Coast 
oyster industry has sufficient capacity to use postharvest processing 
on oysters harvested during the warmer months will not be known. 

* Who would pay to expand processing capacity is not clear. The RTI 
report does not clearly address who would pay for postharvest 
processing, which includes purchasing and installing the equipment, as 
well as transporting harvested oysters to and from postharvest 
processing facilities. The lead author of the RTI report said 
inquiring about possible financial sources available for subsidizing 
the expansion of postharvest processing capacity was beyond the scope 
of the report. However, she suggested that expansion could be 
subsidized by an entity within state government or by an oyster 
industry cooperative that was established to develop a financing 
mechanism. In addition, she said the ISSC could take the lead in 
coordinating the development of the financing mechanisms needed to 
expand postharvest processing facilities. We believe that identifying 
financial support is a major issue in assessing the feasibility of 
requiring postharvest processing, particularly considering state 
government budget constraints and the financial losses the oyster 
industry incurred as a result of the 2010 Deepwater Horizon oil spill 
and the ongoing effects of the recent economic recession. Difficulties 
in obtaining financing could impact the time frame for postharvest 
processing to become operational, and therefore the minimum 2 to 3 
year estimate for increasing capacity might not be reliable. 

* Limited support exists for estimated time frame for increasing 
postharvest processing capacity. According to the RTI report, existing 
processors would need a minimum of 2 years to increase their 
postharvest processing capacity; however, the report does not describe 
in detail the basis for the 2-year estimate. In addition, according to 
the report, it will take at least 3 years to develop the centralized 
postharvest processing facilities. The lead author of the report said 
that the estimates were based, in part, on information obtained from 
surveying Gulf Coast processors. However, the lead author acknowledged 
that few processors contributed cost information associated with 
purchasing, installing, and operating postharvest processing equipment 
because this type of information is proprietary. We recognize the 
proprietary nature of the cost data, but we believe the basis for 
RTI's time frame estimates could be more transparent. For example, the 
report could provide specific time frames associated with the steps 
the report says are required to increase postharvest processing 
capacity. Absent such transparency, it is difficult to know whether 
the estimate is well supported and likely to be accurate. 

* Assumptions about postharvest processing for oysters shipped within 
state borders are likely inaccurate. The RTI report's economic impact 
analysis assumes that three Gulf Coast states--Florida, Texas, and 
Louisiana--would require postharvest processing for oysters harvested 
in the warmer months that are intended for raw consumption and sold 
within the state's borders. However, statutes passed in 2011 in both 
Louisiana and Texas state that federal regulations that prohibit the 
interstate sale of oysters without postharvest processing do not apply 
to oysters harvested and sold within the state.[Footnote 23] By not 
incurring the added cost of postharvest processing, these oysters 
would affect overall oyster prices. The lead author of the RTI report 
agreed that the availability of cheaper nonpostharvest processed raw 
oysters might significantly constrain the ability of retailers and 
restaurateurs, for example, to sell the higher-priced postharvest 
processed oysters. Although the RTI report's analysis includes a range 
of assumptions on the likely proportion of oysters sold within or 
outside of a state's borders, these assumptions are not incorporated 
in the economic impact model. Incorporating them is important because 
they provide oyster processors with important information on whether 
they should make investments in postharvest processing equipment. For 
instance, if some state regulations allow the sale, within state 
borders, of oysters intended for raw consumption without postharvest 
processing, certain processors may decide not to sell oysters outside 
their state to avoid the cost of postharvest processing equipment, 
which would place competitive pressure on all oyster prices. We 
believe that without including a range of assumptions about the 
proportion of oysters likely to be sold both within and outside of a 
state's borders, the overall economic impacts, including the 
likelihood of oyster processors investing in postharvest processing 
capacity, will not be fully known. 

* Postharvest processing costs may not be able to be passed on to 
consumers. The RTI report also assumes that oyster processors can pass 
on some of their postharvest processing costs to consumers. The 
studies cited in the report indicate there is no clear consensus on 
whether any of the postharvest processing costs could be passed on to 
consumers or, if the costs could be passed on, what the amount would 
be. These studies generally found that consumers preferred raw 
unprocessed oysters to postharvest processed oysters, and although 
some were willing to accept postharvest processed oysters, they were 
not necessarily willing to pay a higher price for them. The lead 
author of the RTI report agreed that the report's assumption that 
oyster processors can pass on some of their postharvest processing 
costs to consumers is uncertain. Without the ability to pass on their 
higher costs to consumers, many of the current oyster-processing 
establishments could face closure because, with the addition of 
postharvest processing costs, their total costs may exceed their 
returns. Also, oyster harvesters who depend on these processors may 
have to stop harvesting during the warmer months or quit harvesting 
altogether. Without an analysis that provides a range of estimates for 
the price increase that could be passed on to consumers, the Gulf 
Coast oyster industry will not have sufficient information to help 
determine whether postharvest processing is economically feasible. 

Conclusions: 

It has been nearly 2 years since FDA informed the ISSC that the 
current V. vulnificus illness rate reduction goal does not 
sufficiently protect public health. However, since then, FDA and the 
ISSC have not come to agreement on what an appropriate V. vulnificus 
illness reduction goal should be or on the best strategy to achieve 
such a goal. In the absence of such agreement, it will be very 
difficult for FDA and the ISSC to make progress in reducing the number 
of V. vulnificus illnesses. In addition, the approach FDA and the ISSC 
use to measure progress in reducing V. vulnificus illnesses has three 
main limitations that undermine its credibility. For example, the 
approach is based on data from only four states, including California, 
which has had nearly zero consumption-related V. vulnificus illnesses 
since it began requiring postharvest processing of Gulf Coast oysters 
in 2003. Consequently, the FDA and ISSC measurement approach does not 
provide a credible representation of the Gulf Coast or national impact 
of V. vulnificus illnesses or the real status of their efforts to 
reduce them. Since 2001, FDA, the ISSC, and the Gulf Coast states have 
relied on consumer education and time and temperature controls to 
reduce V. vulnificus illnesses, but neither FDA nor the ISSC has 
routinely evaluated whether these strategies have been effective in 
reducing V. vulnificus illness. Our analysis shows that the extent to 
which the new time and temperature controls will reduce V. vulnificus 
illnesses varies considerably with the level of compliance. Without 
regular evaluations of these illness reduction strategies, FDA, the 
ISSC, and state officials and policymakers have no way of knowing 
whether either strategy has been successful and should be continued or 
is ineffective and should be stopped, which can result in wasted 
resources and a failure to reach policy goals. Finally, FDA has 
concluded that because consumer education and time and temperature 
controls have not resulted in achievement of the 60 percent illness 
rate reduction goal, Gulf Coast oysters harvested during the warmer 
months and intended for raw consumption should be postharvest 
processed to reduce V. vulnificus to nondetectable levels. However, 
the 2011 FDA-commissioned RTI report found that adequate capacity to 
use postharvest processing on all Gulf Coast oysters harvested from 
April through October that are intended for raw consumption does not 
currently exist and is at best 2 to 3 years away. Furthermore, our 
review of the report's economic analysis found several issues that the 
report did not thoroughly address, which could significantly impact 
the feasibility of developing adequate postharvest processing capacity 
specified in the FDA-commissioned report. 

Recommendations for Executive Action: 

To better ensure the safety of oysters from the Gulf of Mexico that 
are sold for raw consumption, we recommend that the Secretary of 
Health and Human Services (HHS) direct the Commissioner of FDA to work 
with the ISSC to take the following four actions: 

* Agree on a nationwide goal for reducing the number of V. vulnificus 
illnesses caused by the consumption of Gulf Coast raw oysters and 
develop strategies to achieve that goal, recognizing that consumer 
education and time and temperature controls have not resulted in 
achievement of the 60 percent V. vulnificus illness rate reduction 
goal and that the capacity to use postharvest processing on Gulf Coast 
oysters harvested from April through October that are intended for raw 
consumption does not currently exist. 

* Correct the limitations in the current approach to measuring 
progress toward the 60 percent V. vulnificus illness rate reduction 
goal or design and implement a new approach without these limitations. 

* Regularly evaluate the effectiveness of V. vulnificus illness 
reduction strategies, such as consumer education and time and 
temperature controls, to determine whether they are successful and 
should be continued or are ineffective and should be stopped. 

* Conduct further study of the six issues of concern we identified 
regarding the RTI report's economic analysis to ensure a more accurate 
assessment of the feasibility of developing adequate capacity and 
before FDA and the ISSC move forward with revising the National 
Shellfish Sanitation Program's shellfish safety guidelines to provide 
postharvest processing for oysters harvested from Gulf Coast waters 
during warmer months and intended for raw consumption. 

Agency Comments and Our Evaluation: 

We provided a draft of this report to HHS and the ISSC for review and 
comment. In written comments, which are included in appendix II, HHS 
provided FDA responses, which generally agreed with the report's four 
recommendations. Specifically, FDA agreed with our first and second 
recommendations. Regarding our third recommendation, FDA agreed that 
the approach used to evaluate the effectiveness of illness reduction 
strategies has limitations that undermine its credibility. FDA also 
said that assessing the effectiveness of existing controls on illness 
reduction is extremely difficult. In an effort to better monitor 
compliance with time and temperature controls, FDA intends to take a 
number of steps, including conducting annual on-site checks at oyster 
landing sites and processing plants to examine compliance with V. 
vulnificus Hazard Analysis and Critical Control Point controls, 
harvester records, time and temperature logs, and actual product 
temperature. We recognize that assessing the effectiveness of V. 
vulnificus illness reduction strategies is difficult, but continue to 
believe it would useful for FDA and the ISSC to attempt to do so, 
because without such evaluations it is difficult to determine whether 
the strategies are successful and should be continued or are 
ineffective and should be stopped. 

Concerning our fourth recommendation, which identified six issues of 
concern in the FDA-commissioned report on postharvest processing 
capacity, FDA agreed to conduct further study or take other actions to 
address our concerns on four issues--key costs are excluded; who would 
pay to expand processing capacity is unclear; support for estimated 
time frame for increasing postharvest processing capacity is limited; 
and assumptions about postharvest processing for oysters shipped 
within state borders are likely inaccurate--but disagreed with one 
issue and neither agreed nor disagreed with the other issue. FDA 
disagreed with our assessment that the 2008 baseline data used in the 
study may not be representative of the Gulf Coast oyster industry. 
Furthermore, FDA said that use of 2010 data would not have represented 
a typical harvest year because the Deepwater Horizon oil spill 
resulted in closures of many Gulf Coast oyster harvest areas, thereby 
reducing oyster harvest levels. However, we did not suggest that 2010 
data be used for the baseline; instead we believe it is preferable to 
use a baseline from either an average of several years or a 
sensitivity analysis of alternative baselines, including one that 
incorporates data for 2010, the year of the Deepwater Horizon oil 
spill and the implementation of the new, more stringent time and 
temperature controls. FDA did not agree or disagree with our 
assessment that postharvest processing costs may not be able to be 
passed on to consumers. Instead, FDA stated that there are many 
uncertainties regarding whether the cost of postharvest processed 
oysters can be passed on to consumers. We believe the FDA- 
commissioned report's analysis could be improved by providing a range 
of postharvest processing cost estimates that can passed on to 
consumers, which would help the oyster industry determine the extent 
to which postharvest processing is economically feasible. FDA also 
provided technical comments, which we incorporated as appropriate. 

The ISSC stated in its written comments--which are included in 
appendix III--that it generally agreed with the recommendations in the 
report. The ISSC also provided additional information on the FDA and 
ISSC efforts to address V. vulnificus illnesses and the circumstances 
that led to the implementation of the current V. vulnificus illness 
reduction strategies. Also, the ISSC commented that the goal of the V. 
vulnificus risk management plans was to reduce V. vulnificus illnesses 
nationally and that four states--California, Florida, Louisiana, and 
Texas--were used to measure effectiveness. However, even though the 
ISSC states that the 60 percent illness rate reduction goal is a 
national goal, it determined achievement toward a national goal by 
calculating the rate of illness for those four states. 

As agreed with your office, unless you publicly announce the contents 
of this report earlier, we plan no further distribution until 30 days 
from the report date. At that time, we will send copies to the 
appropriate congressional committees, the Secretary of Health and 
Human Services, the Executive Director of the Interstate Shellfish 
Sanitation Conference, and other interested parties. In addition, the 
report will be available at no charge on the GAO Web site at 
[hyperlink, http://www.gao.gov]. 

If you or your staff have any questions about this report, please 
contact me at (202) 512-3841 or shamesl@gao.gov. Contact points for 
our Offices of Congressional Relations and Public Affairs may be found 
on the last page of this report. Key contributors to this report are 
listed in appendix IV. 

Sincerely yours, 

Signed by: 

Lisa Shames: 
Director, Natural Resources and Environment: 

[End of section] 

Appendix I: Estimating the Impact of Time and Temperature Controls on 
the Number of Illnesses from V. Vulnificus: 

To estimate the impact of time and temperature controls on the number 
of illnesses from Vibrio vulnificus (V. vulnificus), we took several 
steps. We replicated a model developed by the World Health 
Organization and the Food and Agriculture Organization (WHO/FAO) that 
simulates the risk of illness from V. vulnificus based on several 
factors, such as water temperature and the number of hours that 
harvested oysters are left unrefrigerated.[Footnote 24] We then 
modified the model to simulate the impact of the time and temperature 
controls implemented in Florida, Louisiana, and Texas in May 2010. 
Specifically, we examined the amount of uncertainty in the model's 
estimates of the risk of illness and the impacts of various levels of 
compliance with time and temperature controls on the estimated number 
of V. vulnificus illnesses. 

The Structure of the WHO/FAO Risk Simulation Model: 

The WHO/FAO, in partnership with the Food and Drug Administration 
(FDA), developed a risk simulation model that estimates levels of V. 
vulnificus in raw oysters and the subsequent impact of these levels on 
the risk of illness.[Footnote 25] The risk simulation model was 
presented in a WHO/FAO report on the assessment of risk of V. 
vulnificus in raw oysters.[Footnote 26] To estimate the impact of time 
and temperature controls on the risk of V. vulnificus illnesses, we 
replicated this model and modified it to account for potential changes 
to harvesting and storage practices in response to the imposition of 
time and temperature controls and to analyze various rates of 
compliance with these controls. 

The WHO/FAO risk simulation model is a Monte Carlo simulation, a type 
of numerical analysis that produces a range of estimates to account 
for the natural variability in the model's data inputs and the 
statistical uncertainty in the parameters of the model's equations. 
Data inputs, such as water temperature, vary naturally from day to day 
within a month and from year to year for a given month. Similarly, the 
parameters in the model's equations that estimate V. vulnificus levels 
based on data inputs and that predict the risk of illness based on 
estimated V. vulnificus levels, while based on scientific studies, are 
subject to statistical uncertainty. To account for the variability in 
data inputs and the uncertainty in the parameters of the model's 
equations, the WHO/FAO risk simulation model calculates a range in 
possible estimates of risk, each using slightly different values of 
the data inputs and slightly different values of the parameters. To 
produce a single estimate of the risk of illness, the model first 
estimates levels of V. vulnificus at each of four stages in the 
production process--from harvest to first refrigeration to cooldown to 
consumption. The model then estimates the overall risk of illness 
based on the estimated levels of V. vulnificus at the four stages. 

Figure 8 illustrates each of the stages of the model and the factors 
that influence them. In this figure, the light gray boxes represent 
the input factors, the black boxes represent calculations based on 
those factors, and the arrows indicate which factor influences which 
calculation. For example, water temperature, air temperature and the 
number of hours that oysters are left unrefrigerated are input factors 
that influence the level of V. vulnificus in oysters at the time they 
are first refrigerated. The dark gray box and the dotted arrows 
represent our modification of the WHO/FAO risk simulation model. 
Specifically, we modified the way in which the model determines the 
number of hours that oysters are left unrefrigerated, which will then 
impact the level of V. vulnificus in oysters at the time of cooldown. 
Finally, because V. vulnificus has been found to stop growing and to 
begin dying off when refrigerated at 55 degrees Fahrenheit or below, 
the number of days oysters are refrigerated affects the V. vulnificus 
level at the time oysters are consumed, which affects the number of V. 
vulnificus illnesses that are likely to occur. 

Figure 8: Key Components of WHO/FAO Risk Simulation Model and GAO 
Modifications: 

[Refer to PDF for image: illustration] 

1) Water temperature (Data inputs used in WHO/FAO model): 
Relationships in WHO/FAO model: 
V. vulnificus level at time of harvest; 
Air temperature. 
GAO modification to WHO/FAO model: 
Time and temperature controls. 

2) Air temperature (Data inputs used in WHO/FAO model): 
Relationships in WHO/FAO model: 
V. vulnificus level at time of refrigeration; 
V. vulnificus level at time of cooldown. 

3) V. vulnificus level at time of harvest (Estimates made by WHO/FAO 
model): 
Relationships in WHO/FAO model: 
V. vulnificus level at time of refrigeration. 

4) V. vulnificus level at time of refrigeration (Estimates made by 
WHO/FAO model): 
Relationships in WHO/FAO model: 
V. vulnificus level at time of cooldown. 
Data inputs used in WHO/FAO model: Number of hours unrefrigerated. 

5) V. vulnificus level at time of cooldown (Estimates made by WHO/FAO 
model): 
Relationships in WHO/FAO model: 
V. vulnificus level at time of consumption. 
Data inputs used in WHO/FAO model: Number of hours to cooldown. 

6) V. vulnificus level at time of consumption (Estimates made by 
WHO/FAO model): 
Relationships in WHO/FAO model: 
Illnesses per 100,000 servings (Estimates made by WHO/FAO model): 
Data inputs used in WHO/FAO model: Number of days in refrigeration. 

7) Time and temperature controls (GAO modification to WHO/FAO model): 
GAO modification to WHO/FAO model: 
Number of hours unrefrigerated (Data inputs used in WHO/FAO model); 
Number of hours to cooldown (Data inputs used in WHO/FAO model). 

8) Number of days in refrigeration (Data inputs used in WHO/FAO model): 
V. vulnificus level at time of consumption. 

Source: GAO replication of and modification to WHO/FAO risk simulation 
model. 

Note: The arrow from water temperature to time and temperature 
controls indicates that time and temperature controls vary from month 
to month--the controls are stricter during warmer months and less 
strict during cooler months. 

[End of figure] 

Our Replication and Modification of the WHO/FAO Risk Simulation Model: 

To replicate the WHO/FAO risk simulation model, we took several steps. 
We reviewed the WHO/FAO risk assessment and documented the model's key 
data inputs, assumptions, and equations. We asked FDA modelers, who 
led the development of the WHO/FAO risk simulation model, to review 
our documentation, and we revised our version of the model based on 
their comments. We programmed the model in Statistical Analysis 
Software, generated preliminary estimates, and asked FDA modelers to 
review these estimates, and we compared these estimates to identify 
remaining differences between our version of the model and the version 
used in the WHO/FAO risk assessment. We used the same data inputs as 
reported in the WHO/FAO risk assessment, including the statistical 
distributions of water temperature, the difference between water 
temperature and air temperature, the number of hours that oysters are 
unrefrigerated, the number of hours until oysters cool down to 55 
degrees Fahrenheit, and the number of days that oysters remain in 
refrigeration. We also used the same values as the WHO/FAO risk 
assessment for parameters that convert these data inputs into the 
model's estimates, such as the parameters that define the relationship 
between water temperature and V. vulnificus levels at harvest and the 
parameters that define the relationship between V. vulnificus levels 
at consumption and the risk of illness.[Footnote 27] 

To verify that we correctly replicated the WHO/FAO risk simulation 
model, we compared our estimates to the estimates reported in the WHO/ 
FAO risk assessment for each of the four seasons. Using the same data 
inputs, model parameters, and assumptions, our estimates of the risk 
of illness differ from the estimates reported in the WHO/FAO risk 
assessment by less than 1 percent in the spring, less than 1 percent 
in the summer, 4 percent in the fall, and 42 percent in the winter. 
[Footnote 28] We report only our estimates from the summer months 
because the risk of V. vulnificus illness is greatest during these 
months and because estimates from our model are most similar to the 
estimates from the WHO/FAO model during these months. See table 2 for 
a comparison between the WHO/FAO and GAO estimates for key stages of 
the model for the summer months. 

Table 2: Comparison of Estimates between WHO/FAO Risk Simulation Model 
and GAO Replication of the Model for July, August, and September: 

Variables: Log10 V. vulnificus per gram at time of harvest; 
WHO/FAO risk: simulation model: Mean: 3.27; 
WHO/FAO risk: Standard deviation: 0.64; 
[Empty]; 
GAO replication of risk simulation model: Mean: 3.27; 
GAO replication of risk simulation model: Standard deviation: 0.65; 
[Empty]; 
Percentage difference[A]: Mean: 0.00; 
Percentage difference[A]: Standard deviation: 1.50. 

Variables: Log10 V. vulnificus per gram growth prior to refrigeration; 
WHO/FAO risk: simulation model: 
Mean: 0.68; 
Standard deviation: 0.35; 
GAO replication of risk simulation model: 
Mean: 0.69; 
Standard deviation: 0.34; 
Percentage difference[A]: 
Mean: 1.45%; 
Standard deviation: -2.86%. 

Variables: Log10 V. vulnificus per gram growth during cooldown; 
WHO/FAO risk: simulation model: 
Mean: 0.50; 
Standard deviation: 0.22; 
GAO replication of risk simulation model: 
Mean: 0.50; 
Standard deviation: 0.22; 
Percentage difference[A]: 
Mean: 0.00; 
Standard deviation: 0.00. 

Variables: Log10 V. vulnificus per gram die-off during 
refrigeration[B]; 
WHO/FAO risk: simulation model: 
Mean: 0.31; 
Standard deviation: n/a[D]; 
GAO replication of risk simulation model: 
Mean: 0.32; 
Standard deviation: 0.15; 
Percentage difference[A]: 
Mean: 3.13%; 
Standard deviation: n/a[D]. 

Variables: Number of V. vulnificus Illnesses per 100,000 Servings; 
WHO/FAO risk: simulation model: 
Mean: 4.28; 
Standard deviation: 90 percent uncertainty interval (3.69-4.97)[C]; 
GAO replication of risk simulation model: 
Mean: 4.30; 
Standard deviation: 90 percent uncertainty interval (3.62-5.19)[C]; 
Percentage difference[A]: 
Mean: 0.47; 
Standard deviation: n/a[E]. 

Source: WHO/FAO risk assessment and GAO replication of WHO/FAO risk 
simulation model. 

[A] Estimates reported in the WHO/FAO risk assessment were rounded to 
two numbers past the decimal point. As a result, the calculations of 
percentage difference between the WHO/FAO estimates and the GAO 
estimates may be subject to rounding errors. 

[B] V. vulnificus per gram die-off implies a reduction in bacterial 
levels during refrigeration. Therefore, although the estimates are 
presented as positive numbers, they refer to a decrease in V. 
vulnificus levels. 

[C] To be consistent with the estimates in the WHO/FAO risk 
assessment, we present the 90 percent uncertainty interval for the 
number of V. vulnificus illnesses per 100,000 servings, rather than 
the standard deviation. 

[D] The standard deviation of the Log10 V. vulnificus per gram die-off 
rate during refrigeration was not reported in the WHO/FAO risk 
assessment. 

[E] For simplicity, the percentage differences between the upper and 
lower bound of the 90 percent uncertainty intervals are omitted, 
although the information provided in the table allows these percentage 
differences to be calculated. 

[End of table] 

After verifying that we replicated the WHO/FAO risk simulation model, 
we modified it to simulate the impact of time and temperature controls 
in Florida, Louisiana, and Texas. Since time and temperature controls 
are specific to each state and each month, we modified the model to 
provide the estimated risk of V. vulnificus illness for each state and 
each month. In particular, we used monthly, rather than seasonal, 
parameters that were reported in the WHO/FAO risk assessment to 
estimate water temperature and the difference between water 
temperature and air temperature. In addition, the WHO/FAO risk 
assessment reported parameters for the distribution of the number of 
hours that oysters are left unrefrigerated separately for Louisiana 
and for the rest of the Gulf Coast states. We applied these parameters 
to our simulation, using one set of parameters for Louisiana and 
another set of parameters for Florida and Texas. The WHO/FAO risk 
assessment model's estimates are based on the average of 100 samples 
of 10,000 observations each. To provide more reliable uncertainty 
intervals for these estimates, our modification of the WHO/FAO model 
uses 1,000 samples. 

Time and Temperature Controls for Florida, Louisiana, and Texas and 
Our Simulations of Various Compliance Rates with the Controls: 

Effective May 1, 2010, Florida, Louisiana, and Texas implemented new, 
more stringent time and temperature controls that specify (1) the 
maximum number of hours that oysters are allowed to be unrefrigerated 
after being harvested and (2) the maximum number of hours before 
refrigerated oysters must cool down to 55 degrees Fahrenheit. The new 
more stringent controls established by the three states for 2010 and 
incorporated in their risk management plans are presented in table 3 
for each state and each month. These controls are stricter during the 
warmer months when V. vulnificus bacteria multiply more quickly. In 
August, for example, Louisiana and Texas have the most restrictive 
controls for the time oysters could remain unrefrigerated, allowing 1 
hour from harvest until refrigeration, and Florida has the most 
restrictive controls for the time until refrigerated oysters must cool 
down, allowing 2 hours from when they are first refrigerated until 
they reach 55 degrees Fahrenheit. 

Table 3: Time and Temperature Controls for 2010, by State and Month: 

Maximum number of hours: 

Month: January; 
From harvest to refrigeration, Florida: 18; 
From harvest to refrigeration, Louisiana: 36; 
From harvest to refrigeration, Texas: 18; 
From refrigeration to cooldown to 55 degrees Fahrenheit, Florida: 10; 
From refrigeration to cooldown to 55 degrees Fahrenheit, Louisiana: 10; 
From refrigeration to cooldown to 55 degrees Fahrenheit, Texas: 10. 

Month: February; 
From harvest to refrigeration, Florida: 18; 
From harvest to refrigeration, Louisiana: 36; 
From harvest to refrigeration, Texas: 18; 
From refrigeration to cooldown to 55 degrees Fahrenheit, Florida: 10; 
From refrigeration to cooldown to 55 degrees Fahrenheit, Louisiana: 10; 
From refrigeration to cooldown to 55 degrees Fahrenheit, Texas: 10. 

Month: March; 
From harvest to refrigeration, Florida: 18; 
From harvest to refrigeration, Louisiana: 8; 
From harvest to refrigeration, Texas: 18; 
From refrigeration to cooldown to 55 degrees Fahrenheit, Florida: 10; 
From refrigeration to cooldown to 55 degrees Fahrenheit, Louisiana: 10; 
From refrigeration to cooldown to 55 degrees Fahrenheit, Texas: 10. 

Month: April; 
From harvest to refrigeration, Florida: 12; 
From harvest to refrigeration, Louisiana: 8; 
From harvest to refrigeration, Texas: 10; 
From refrigeration to cooldown to 55 degrees Fahrenheit, Florida: 10; 
From refrigeration to cooldown to 55 degrees Fahrenheit, Louisiana: 10; 
From refrigeration to cooldown to 55 degrees Fahrenheit, Texas: 10. 

Month: May; 
From harvest to refrigeration, Florida: 6; 
From harvest to refrigeration, Louisiana: 1; 
From harvest to refrigeration, Texas: 4; 
From refrigeration to cooldown to 55 degrees Fahrenheit, Florida: 2; 
From refrigeration to cooldown to 55 degrees Fahrenheit, Louisiana: 6; 
From refrigeration to cooldown to 55 degrees Fahrenheit, Texas: 6. 

Month: June; 
From harvest to refrigeration, Florida: 6; 
From harvest to refrigeration, Louisiana: 1; 
From harvest to refrigeration, Texas: 3; 
From refrigeration to cooldown to 55 degrees Fahrenheit, Florida: 2; 
From refrigeration to cooldown to 55 degrees Fahrenheit, Louisiana: 6; 
From refrigeration to cooldown to 55 degrees Fahrenheit, Texas: 6. 

Month: July; 
From harvest to refrigeration, Florida: 6; 
From harvest to refrigeration, Louisiana: 1; 
From harvest to refrigeration, Texas: 1; 
From refrigeration to cooldown to 55 degrees Fahrenheit, Florida: 2; 
From refrigeration to cooldown to 55 degrees Fahrenheit, Louisiana: 6; 
From refrigeration to cooldown to 55 degrees Fahrenheit, Texas: 6. 

Month: August; 
From harvest to refrigeration, Florida: 6; 
From harvest to refrigeration, Louisiana: 1; 
From harvest to refrigeration, Texas: 1; 
From refrigeration to cooldown to 55 degrees Fahrenheit, Florida: 2; 
From refrigeration to cooldown to 55 degrees Fahrenheit, Louisiana: 6; 
From refrigeration to cooldown to 55 degrees Fahrenheit, Texas: 6. 

Month: September; 
From harvest to refrigeration, Florida: 6; 
From harvest to refrigeration, Louisiana: 1; 
From harvest to refrigeration, Texas: 3; 
From refrigeration to cooldown to 55 degrees Fahrenheit, Florida: 2; 
From refrigeration to cooldown to 55 degrees Fahrenheit, Louisiana: 6; 
From refrigeration to cooldown to 55 degrees Fahrenheit, Texas: 6. 

Month: October; 
From harvest to refrigeration, Florida: 6; 
From harvest to refrigeration, Louisiana: 1; 
From harvest to refrigeration, Texas: 4; 
From refrigeration to cooldown to 55 degrees Fahrenheit, Florida: 2; 
From refrigeration to cooldown to 55 degrees Fahrenheit, Louisiana: 6; 
From refrigeration to cooldown to 55 degrees Fahrenheit, Texas: 6. 

Month: November; 
From harvest to refrigeration, Florida: 18; 
From harvest to refrigeration, Louisiana: 8; 
From harvest to refrigeration, Texas: 10; 
From refrigeration to cooldown to 55 degrees Fahrenheit, Florida: 10; 
From refrigeration to cooldown to 55 degrees Fahrenheit, Louisiana: 10; 
From refrigeration to cooldown to 55 degrees Fahrenheit, Texas: 10. 

Month: December; 
From harvest to refrigeration, Florida: 18; 
From harvest to refrigeration, Louisiana: 36; 
From harvest to refrigeration, Texas: 18; 
From refrigeration to cooldown to 55 degrees Fahrenheit, Florida: 10; 
From refrigeration to cooldown to 55 degrees Fahrenheit, Louisiana: 10; 
From refrigeration to cooldown to 55 degrees Fahrenheit, Texas: 10. 

Source: GAO analysis of Florida, Louisiana, and Texas 2010 risk 
management plans. 

[A] The number of hours to cooldown for Florida refers to the rapid 
cooling control option, one of four time and temperature control 
options authorized in Florida's V. vulnificus risk management plan and 
the only option used during the summer of 2010 by the Florida oyster 
industry, according to a senior Florida regulatory official. 

[End of table] 

For the purpose of this analysis, we define the baseline scenario as 
the risk of illness in the absence of the new, more stringent time and 
temperature controls. Under the baseline scenario, the WHO/FAO risk 
simulation model assumes a certain statistical distribution in the 
number of hours that oysters ordinarily would be left unrefrigerated. 
The values in the statistical distribution, which is based on 
assumptions in the risk simulation model, range from 1 hour to 10 or 
more hours, depending upon the state and the month, and specifies the 
percentage of oysters that ordinarily would be left unrefrigerated for 
any given number of hours within this range. Based on this statistical 
distribution, we estimated the percentage of oysters that ordinarily-- 
that is, in the absence of the new, more stringent time and 
temperature controls--would be refrigerated within the maximum number 
of hours established by time and temperature controls for each state 
and each month. In states and months with the least stringent 
controls, a majority of oysters ordinarily would be refrigerated 
within these time limits, even in the absence of these time and 
temperature controls. For example, in Florida during the three summer 
months, according to the assumed statistical distribution, 
approximately 85 percent of oysters harvested ordinarily would be 
refrigerated within the 6-hour limit established by the new, more 
stringent time and temperature controls. By contrast, in states and 
months with the most stringent controls, fewer oysters harvested would 
ordinarily be refrigerated within these limits. For example, in 
Louisiana and Texas in August, virtually none of the harvested oysters 
ordinarily would be refrigerated within the 1-hour limit established 
by these time and temperature controls, according to the assumed 
statistical distribution. 

To simulate compliance with the maximum number of hours that oysters 
are allowed to be unrefrigerated under applicable time and temperature 
controls, we make the following assumptions about the behavior of 
oyster harvesters. First, harvesters that ordinarily--that is, under 
the baseline scenario--would leave oysters unrefrigerated for less 
than the maximum number of hours would continue to leave them 
unrefrigerated for the same number of hours that they ordinarily would 
have. Second, harvesters who ordinarily would leave oysters 
unrefrigerated for more than the maximum number of hours, and who 
decide to change to comply with time and temperature controls, would 
leave oysters unrefrigerated for no more than the maximum allowed 
number of hours. Third, harvesters who ordinarily would leave oysters 
unrefrigerated for more than the maximum number of hours, but who 
decide not to change to comply with time and temperature controls, 
would continue to leave oysters unrefrigerated for the same number of 
hours that they ordinarily would have. Similarly, to model the impact 
of compliance on the number of hours until oysters reach the desired 
55 degrees Fahrenheit, we assumed that producers would facilitate more 
rapid cooling so that oysters would take no longer than the maximum 
number of hours to cooldown. 

Using these assumptions, we developed 10 compliance scenarios for each 
state and each month. These scenarios correspond to estimated 
compliance rates of 10 percent through 100 percent in increments of 
10. Under these scenarios, the model first estimates the percentage of 
oysters that ordinarily would be refrigerated within the maximum 
number of hours established by time and temperature controls for each 
state and each month. To obtain a given compliance rate, the model 
calculates the additional percentage of oysters that would need to be 
refrigerated within the maximum number of hours by time and 
temperature controls to reach a given rate of compliance with regard 
to the maximum time allowed to be unrefrigerated. For this additional 
percentage of oysters, the model assumes that oysters would be 
refrigerated within the maximum number of hours allowed by the 
controls for that state and month. In Florida during the three summer 
months, for example, 85 percent of oysters are assumed to be 
refrigerated within the 6-hour limit in the absence of time and 
temperature controls, based on the assumed statistical distribution. 
To attain a 90 percent compliance rate, the model would select the 
additional 5 percent of oysters, from among the 15 percent that exceed 
the limit, and would assume that these oysters would be unrefrigerated 
for no longer than 6 hours. Since actual compliance rates are unknown, 
these calculations allow us to estimate the number of hours that 
oysters would be unrefrigerated assuming various compliance rates. 

Estimates of the Number of V. Vulnificus Illnesses Using FDA's Risk 
Calculator: 

The three states used FDA's risk calculator and their own input data, 
including water temperature and air temperature for each month, to 
establish the specific limits for time and temperature controls. The 
risk calculator, which was developed by FDA, is a simplified version 
of the WHO/FAO risk simulation model and operates in a computer 
spreadsheet. It allows the user to estimate the risk of illness from 
V. vulnificus under various scenarios, such as different limits for 
the maximum number of hours that oysters can left be unrefrigerated. 
To determine the estimated number of illnesses per 100,000 servings of 
raw oysters (i.e., risk of illness) consumed by the susceptible 
population for each state and month under time and temperature 
controls, we used FDA's risk calculator. To make the results of our 
analysis comparable across the states and consistent with the 
assumptions of the baseline scenario, we used the input data for water 
temperature and air temperature from the WHO/FAO risk simulation 
model, rather than the data used by the states. As a result, our 
estimates of the risk of illness differ somewhat from the estimates 
that the states made in using the risk calculator to develop their 
risk management plans. 

Unlike the states, we estimated the number of illnesses per 100,000 
servings of raw oysters consumed by the susceptible population, rather 
than the total number of illnesses, because (1) time and temperature 
controls are designed to affect the risk of illness per serving, not 
the total number of raw oyster servings consumed and (2) complete 
state-by-state and month-by-month data on the number of raw oyster 
servings consumed were not available. The estimated number of 
illnesses per 100,000 servings for each state and each month, as 
computed by the risk calculator, is presented in table 4. These 
estimates represent the number of illnesses that states would expect, 
based on the risk calculator, as a result of time and temperature 
controls. We compared these estimated numbers of illnesses, for each 
state and each month, to the estimates of our modification of the risk 
simulation model, which accounts for uncertainty in the estimates and 
for various compliance rates. 

Effect of Uncertainty and Compliance Rates on the Likely Impact of 
Time and Temperature Controls on the Number of V. Vulnificus Illnesses: 

FDA's risk calculator estimates the same number of V. vulnificus 
illnesses as the WHO/FAO risk simulation model, on average. Unlike the 
risk simulation model, however, the risk calculator does not provide 
uncertainty distributions associated with these estimates. Using our 
modification of the WHO/FAO risk simulation model, we computed the 
amount of uncertainty associated with estimates made by FDA's risk 
calculator. In any given month and in any given state, uncertainty in 
model assumptions may cause the actual number of illnesses to differ 
from the number estimated by the risk calculator. For example, in 
Texas in the month of August, FDA's risk calculator estimates that 
time and temperature controls will lead to 2.84 illnesses per 100,000 
raw oyster servings consumed by the susceptible population. While this 
is true on average, the number of illnesses per 100,000 servings could 
vary from the lower bound of 2.44 to the upper bound 3.63 (for a 90 
percent uncertainty interval), according to our analysis. We find a 
similar range of uncertainty in the estimated number of V. vulnificus 
illnesses for Florida and Louisiana. Table 4 presents our estimates 
compared with estimates made by the risk calculator, assuming 100 
percent compliance with time and temperature controls for the three 
states during the summer months. 

Table 4: Comparison of FDA's Risk Calculator and GAO's Modification of 
WHO/FAO Risk Simulation Model Concerning Estimated Number of V. 
Vulnificus Illnesses per 100,000 Servings of Oysters at Baseline: 

Florida: 

Month: July; 
FDA risk calculator--mean[A]: 3.46; 
GAO's modification of WHO/FAO risk simulation model--lower bound[B]: 
2.87; 
GAO's modification of WHO/FAO risk simulation model--mean: 3.47; 
GAO's modification of WHO/FAO risk simulation model--upper bound[C]: 
4.23. 

Month: August; 
FDA risk calculator--mean[A]: 3.45; 
GAO's modification of WHO/FAO risk simulation model--lower bound[B]: 
3.00; 
GAO's modification of WHO/FAO risk simulation model--mean: 3.53; 
GAO's modification of WHO/FAO risk simulation model--upper bound[C]: 
4.30. 

Month: September; 
FDA risk calculator--mean[A]: 3.05; 
GAO's modification of WHO/FAO risk simulation model--lower bound[B]: 
2.51; 
GAO's modification of WHO/FAO risk simulation model--mean: 3.05; 
GAO's modification of WHO/FAO risk simulation model--upper bound[C]: 
3.69. 

Louisiana: 

Month: July; 
FDA risk calculator--mean[A]: 2.84; 
GAO's modification of WHO/FAO risk simulation model--lower bound[B]: 
2.33; 
GAO's modification of WHO/FAO risk simulation model--mean: 2.89; 
GAO's modification of WHO/FAO risk simulation model--upper bound[C]: 
3.53. 

Month: August; 
FDA risk calculator--mean[A]: 2.84; 
GAO's modification of WHO/FAO risk simulation model--lower bound[B]: 
2.44; 
GAO's modification of WHO/FAO risk simulation model--mean: 2.95; 
GAO's modification of WHO/FAO risk simulation model--upper bound[C]: 
3.63. 

Month: September; 
FDA risk calculator--mean[A]: 2.52; 
GAO's modification of WHO/FAO risk simulation model--lower bound[B]: 
2.02; 
GAO's modification of WHO/FAO risk simulation model--mean: 2.54; 
GAO's modification of WHO/FAO risk simulation model--upper bound[C]: 
3.11. 

Texas: 

Month: July; 
FDA risk calculator--mean[A]: 2.84; 
GAO's modification of WHO/FAO risk simulation model--lower bound[B]: 
2.33; 
GAO's modification of WHO/FAO risk simulation model--mean: 2.89; 
GAO's modification of WHO/FAO risk simulation model--upper bound[C]: 
3.53. 

Month: August; 
FDA risk calculator--mean[A]: 2.84; 
GAO's modification of WHO/FAO risk simulation model--lower bound[B]: 
2.44; 
GAO's modification of WHO/FAO risk simulation model--mean: 2.95; 
GAO's modification of WHO/FAO risk simulation model--upper bound[C]: 
3.63. 

Month: September; 
FDA risk calculator--mean[A]: 2.85; 
GAO's modification of WHO/FAO risk simulation model--lower bound[B]: 
2.33; 
GAO's modification of WHO/FAO risk simulation model--mean: 2.86; 
GAO's modification of WHO/FAO risk simulation model--upper bound[C]: 
3.48. 

Source: GAO analysis with FDA's risk calculator and GAO's modification 
of the WHO/FAO risk simulation model. 

Notes: These estimates assume 100 percent compliance with state time 
and temperature controls. 

[A] Estimates made with the FDA's risk calculator do not produce 
uncertainty intervals, so we only report a mean estimate, rather than 
a mean plus a lower bound and an upper bound. 

[B] The lower bound is based on the 5th percentile of the distribution 
of risk calculations from our modification of the WHO/FAO risk 
simulation model. 

[C] The upper bound is based on the 95th percentile of the 
distribution of risk calculations from our modification of the WHO/FAO 
risk simulation model. 

[End of table] 

Furthermore, we estimate that time and temperature controls would 
result in a smaller reduction in the number of V. vulnificus illnesses 
if compliance rates are less than 100 percent. Table 5 shows the 
estimated reduction in V. vulnificus illnesses as a result of time and 
temperature controls for various compliance rates for each of the 
three states during the summer months, based on our modification of 
the WHO/FAO risk simulation model. For example, during August, 
assuming that 100 percent of oysters are harvested in compliance with 
time and temperature controls, our analysis estimates these controls 
will reduce illnesses by between 16 percent and 27 percent in Florida, 
between 30 percent and 47 percent in Louisiana, and between 26 percent 
and 43 percent in Texas. If compliance is less than 100 percent, 
however, we estimate that these controls will lead to a much smaller 
reduction in illnesses. As can be seen in table 5, if 90 percent of 
oysters are harvested in compliance with time and temperature 
controls--meaning a noncompliance rate of 10 percent--the illness 
reduction is smaller than the illness reduction under the assumption 
of 100 percent compliance. For example, in the month of August, we 
estimate that illnesses would be reduced between 11 percent and 18 
percent in Florida, between 21 percent and 32 percent in Louisiana, 
and between 19 percent and 31 percent in Texas, assuming 90 percent 
compliance. Furthermore, if 80 percent of oysters are harvested in 
compliance with these controls--meaning that noncompliance rates are 
20 percent--the estimated illness reduction is smaller still. In 
particular, we estimate that illnesses would be reduced between 8 
percent and 14 percent in Florida, between 15 percent and 23 percent 
in Louisiana, and between 14 percent and 22 percent in Texas. At lower 
levels of compliance, an even smaller reduction in the number of V. 
vulnificus illnesses is likely. 

Table 5: Estimated Percentage Reduction in the Number of V. Vulnificus 
Illnesses as a Result of Time and Temperature Controls, by State and 
Month: 

Florida: 

July; 
100 percent compliance: 
Lower bound[A]: 17; 
Mean: 22; 
100 percent compliance: 
90 percent compliance: 
Lower bound[A]: 11; 
Mean: 15; 
Upper bound[B]: 18; 
80 percent compliance[C]: 
Lower bound[A]: 8; 
Mean: 11; 
Upper bound[B]: 14; 
70 percent compliance[C]: 
Lower bound[A]: 7; 
Mean: 9; 
Upper bound[B]: 11. 

August; 
100 percent compliance: 
Lower bound[A]: 16; 
Mean: 21; 
Upper bound[B]: 27; 
90 percent compliance: 
Lower bound[A]: 11; 
Mean: 14; 
Upper bound[B]: 18; 
80 percent compliance[C]: 
Lower bound[A]: 8; 
Mean: 11; 
Upper bound[B]: 14; 
70 percent compliance[C]: 
Lower bound[A]: 7; 
Mean: 9; 
Upper bound[B]: 11. 

September; 
100 percent compliance: 
Lower bound[A]: 17; 
Mean: 22; 
Upper bound[B]: 29; 
90 percent compliance: 
Lower bound[A]: 12; 
Mean: 16; 
Upper bound[B]: 20; 
80 percent compliance[C]: 
Lower bound[A]: 9; 
Mean: 11; 
Upper bound[B]: 15; 
70 percent compliance[C]: 
Lower bound[A]: 7; 
Mean: 9; 
Upper bound[B]: 12. 

Louisiana: 

July; 
100 percent compliance: 
Lower bound[A]: 31; 
Mean: 39; 
Upper bound[B]: 48; 
90 percent compliance: 
Lower bound[A]: 21; 
Mean: 26; 
Upper bound[B]: 32; 
80 percent compliance[C]: 
Lower bound[A]: 15; 
Mean: 19; 
Upper bound[B]: 23; 
70 percent compliance[C]: 
Lower bound[A]: 11; 
Mean: 14; 
Upper bound[B]: 17. 

August; 
100 percent compliance: 
Lower bound[A]: 30; 
Mean: 38; 
Upper bound[B]: 47; 
90 percent compliance: 
Lower bound[A]: 21; 
Mean: 26; 
Upper bound[B]: 32; 
80 percent compliance[C]: 
Lower bound[A]: 15; 
Mean: 19; 
Upper bound[B]: 24; 
70 percent compliance[C]: 
Lower bound[A]: 11; 
Mean: 14; 
Upper bound[B]: 17. 

September; 
100 percent compliance: 
Lower bound[A]: 31; 
Mean: 39; 
Upper bound[B]: 49; 
90 percent compliance: 
Lower bound[A]: 23; 
Mean: 28; 
Upper bound[B]: 35; 
80 percent compliance[C]: 
Lower bound[A]: 16; 
Mean: 20; 
Upper bound[B]: 25; 
70 percent compliance[C]: 
Lower bound[A]: 11; 
Mean: 14; 
Upper bound[B]: 18. 

Texas: 

July; 
100 percent compliance: 
Lower bound[A]: 27; 
Mean: 35; 
Upper bound[B]: 43; 
90 percent compliance: 
Lower bound[A]: 19; 
Mean: 24; 
Upper bound[B]: 30; 
80 percent compliance[C]: 
Lower bound[A]: 14; 
Mean: 18; 
Upper bound[B]: 22; 
70 percent compliance[C]: 
Lower bound[A]: 10; 
Mean: 13; 
Upper bound[B]: 15. 

August; 
100 percent compliance: 
Lower bound[A]: 26; 
Mean: 34; 
Upper bound[B]: 43; 
90 percent compliance: 
Lower bound[A]: 19; 
Mean: 25; 
Upper bound[B]: 31; 
80 percent compliance[C]: 
Lower bound[A]: 14; 
Mean: 18; 
Upper bound[B]: 22; 
70 percent compliance[C]: 
Lower bound[A]: 10; 
Mean: 13; 
Upper bound[B]: 16. 

September; 
100 percent compliance: 
Lower bound[A]: 21; 
Mean: 27; 
Upper bound[B]: 34; 
90 percent compliance: 
Lower bound[A]: 15; 
Mean: 19; 
Upper bound[B]: 24; 
80 percent compliance[C]: 
Lower bound[A]: 10; 
Mean: 13; 
Upper bound[B]: 17; 
70 percent compliance[C]: 
Lower bound[A]: 6; 
Mean: 8; 
Upper bound[B]: 11. 

Source: GAO modification of the WHO/FAO risk simulation model. 

[A] The lower bound is based on the 5th percentile of the distribution 
of calculations. 

[B] The upper bound is based on the 95th percentile of the 
distribution of calculations. 

[C] Under the baseline scenario, approximately 85 percent of oysters 
in Florida in July, August, and September are assumed to be 
refrigerated within the maximum number of hours allowed by time and 
temperature controls. As a result, we assume that compliance rates for 
Florida during the summer will be no lower than 85 percent for time-to-
refrigeration controls. Therefore, the 80 percent and 70 percent 
compliance scenarios for Florida refer only to compliance with 
refrigeration to cooldown controls. 

[End of table] 

Because time and temperature controls are less effective at lower 
compliance rates, the probability that these controls will lead to the 
illness reduction estimated by the risk calculator is also lower when 
compliance rates are lower. Table 6 shows the probability that time 
and temperature controls will reduce V. vulnificus illnesses to the 
number estimated by FDA's risk calculator or lower for various 
compliance rates for each of the three states, based on our risk 
simulation model. During the summer, assuming that 100 percent of 
oysters are harvested in compliance with time and temperature 
controls, as would be expected with the risk calculator's design, 
there is between a 43 percent chance and a 55 percent chance that 
these controls will reduce illnesses to the number estimated by the 
risk calculator or lower, depending on the state and the month. If 
compliance is less than 100 percent, however, our analysis shows that 
it is unlikely that time and temperature controls will reduce 
illnesses to the number estimated by the risk calculator or lower. As 
can be seen in table 5, if 90 percent of oysters are harvested in 
compliance with time and temperature controls--meaning a noncompliance 
rate of 10 percent--the chances that these controls will reduce 
illnesses to the estimated number or lower drop substantially when 
compared with the chances under the assumption of 100 percent 
compliance. In particular, for the month of August, we estimate that 
the probability drops from 48 percent to 18 percent in Florida, from 
43 percent to 2 percent in Louisiana, and from 43 percent to 4 percent 
in Texas. Furthermore, if 80 percent of oysters are harvested in 
compliance with these controls--meaning that noncompliance rates are 
20 percent--the likelihood of success is smaller still. In particular, 
we estimate that the probability that these controls will reduce 
illnesses to the number estimated by the risk calculator or lower 
drops to 7 percent in Florida, less than 1 percent in Louisiana, and 
1 percent in Texas. 

Table 6: Probability That the Time and Temperature Controls Will 
Reduce V. Vulnificus Illnesses to the Number Estimated by FDA's Risk 
Calculator or Lower, by Estimated Compliance Rate[A]: 

Florida: 

Month: July; 
Estimated compliance rate[B]: 
100 percent: 0.54; 
Estimated compliance rate[B]: 
90 percent: 0.22; 
80 percent: 0.11[C]; 
70 percent: 0.08[C]. 

Month: August; 
Estimated compliance rate[B]: 
100 percent: 0.48; 
90 percent: 0.18; 
80 percent: 0.07[C]; 
70 percent: 0.05. 

Month: September; 
Estimated compliance rate[B]: 
100 percent: 0.55; 
90 percent: 0.24; 
80 percent: 0.10[C]; 
70 percent: 0.07[C]. 

Louisiana: 

Month: July; 
Estimated compliance rate[B]: 
100 percent: 0.47;
90 percent: 0.03; 
80 percent: 0.00; 
70 percent: 0.00. 

Month: August; 
Estimated compliance rate[B]: 
100 percent: 0.43; 
90 percent: 0.02; 
80 percent: 0.00; 
70 percent: 0.00. 

Month: September; 
Estimated compliance rate[B]: 
100 percent: 0.50; 
90 percent: 0.06; 
80 percent: 0.00; 
70 percent: 0.00. 

Texas: 

Month: July; 
Estimated compliance rate[B]: 
100 percent: 0.47; 
90 percent: 0.07; 
80 percent: 0.01; 
70 percent: 0.00. 

Month: August; 
Estimated compliance rate[B]: 
100 percent: 0.43; 
90 percent: 0.04; 
80 percent: 0.01; 
70 percent: 0.00. 

Month: September; 
Estimated compliance rate[B]: 
100 percent: 0.52; 
90 percent: 0.17; 
80 percent: 0.04; 
70 percent: 0.01. 

Source: GAO modification of the WHO/FAO risk simulation model. 

[A] Probabilities are expressed between 0.00 and 1.00, with values 
close to 0.00 being highly unlikely and values close to 1.00 being 
highly likely. 

[B] Compliance rates are estimated based on the distribution of time 
to refrigeration and time to cooldown, which is used in both the 
WHO/FAO risk simulation and in GAO's modification of the WHO/FAO risk 
simulation model, in combination with the thresholds established by 
time and temperature controls. 

[C] Under the baseline scenario, approximately 85 percent of oysters 
in Florida in July, August, and September are assumed to be 
refrigerated within the maximum number of hours allowed by time and 
temperature controls. As a result, we assume that compliance rates for 
Florida during the summer will be no lower than 85 percent for time-to-
refrigeration controls. Therefore, the 80 percent and 70 percent 
compliance scenarios for Florida refer only to compliance with 
refrigeration to cooldown controls. 

[End of table] 

Limitations to Our Analysis: 

Like all quantitative models, our analysis is subject to certain 
limitations. First, our analysis is subject to all of the limitations 
to which the WHO/FAO risk simulation model is subject. Though the WHO/ 
FAO model is based on credible scientific studies, uses a valid and 
reliable methodology, and predicts actual illnesses rates with 
reasonable accuracy, it is subject to limitations just as all 
quantitative models are. For example, the model assumes that V. 
vulnificus levels at harvest are only determined by water temperature, 
that all strains of V. vulnificus are equally virulent, and that the 
risk of infection is identical for all members of the susceptible 
population, though these are simplifications. Furthermore, the exact 
relationship between levels of V. vulnificus and the observed number 
of illness is not known, and there are no precise estimates of the 
size of the susceptible population. Second, our simulations of 
compliance rates are based on certain assumptions about handling of 
oysters under the baseline scenario--including the number of hours 
that oysters would be unrefrigerated and the number of hours until 
oysters cool down--and on certain assumptions about how producers 
might respond to time and temperature controls under various 
compliance scenarios. Since we do not have direct data on actual 
compliance rates, however, our estimates are only an approximation and 
cannot be validated against observed data. Third, our estimates of the 
probability that time and temperature controls will lead to the levels 
of illness estimated by the risk calculator are approximations and are 
a function of the data inputs, assumptions, and equations in the risk 
simulation model. In spite of these limitations, however, we believe 
our estimates are sufficiently reliable to demonstrate that there is a 
substantial chance that time and temperature controls will not lead to 
the number of V. vulnificus illnesses estimated by the risk calculator 
or lower, especially with less than perfect compliance rates. 

[End of section] 

Appendix II: Comments from the Department of Health and Human Services: 

Department Of Health & Human Services: 
Office Of The Secretary: 
Assistant Secretary for Legislation: 
Washington, DC 20201: 

August 15, 2011: 

Lisa Shames: 
Director, Natural Resources and Environment:
U.S. Government Accountability Office: 
441 G Street N.W. 
Washington, DC 20548: 

Dear Mr. Kohn: 

Attached are comments on the U.S. Government Accountability Office's 
(GAO) draft report entitled: "Food Safety: FDA Needs to Reassess Its 
Approach to Reducing an Illness Caused by Eating Raw Oysters" (GA0-11-
607). 

The Department appreciates the opportunity to review this report 
before its publication. 

Sincerely, 

Signed by: 

Jim R. Esquea: 
Assistant Secretary for Legislation: 

Attachment: 

[End of letter] 

General Comments Of The Department Of Health And Human Services (HHS) 
On The Government Accountability Office'S (GAO) Draft Report Entitled. 
"Food Safety: FDA Needs To Reassess Its Approach To Reducing An 
Illness Caused By Eating Raw Oysters" (GAO-11-607): 

The Department appreciates the opportunity to review and comment on 
this draft report. Vibrio Vulnificus (V. vulnificus) is a naturally 
occurring bacterium that can cause a severe and life threatening 
illness that is fatal about 50 % of the time, generally causing about 
15 deaths per year. V. vulnificus is associated with the consumption 
of raw oysters and characterized by fever and chills, decreased blood 
pressure (septic shock), and blistering skin lesions. At greatest risk 
are individuals whose immune systems have been compromised or who have 
certain health conditions, such as liver, stomach, or blood disorders; 
cancer; AIDS; diabetes; kidney disease; and chronic alcohol abuse. 

Effective technologies have been developed that can largely eliminate 
the hazard of V. vulnificus while producing oysters that retain the 
sensory qualities of untreated product. These technologies, known as 
Post Harvest Processing (PHP), include individual quick freezing (IQF) 
with extended frozen storage, high hydrostatic pressure, mild heat, 
and low dose gamma irradiation. PHP technologies have proven to be 
effective in eradicating V. vulnificus associated illness. For 
example, in 2003, the State of California prohibited Gulf Coast 
oysters from entering the state during the season of greatest risk 
unless they had undergone PHP. Once PHP was required in California, 
the number of deaths in the state fell from 40, between 1991 to 2001, 
to nearly zero since then. California's PHP requirement has virtually 
eliminated the state's V. vulnificus-related deaths and illness from 
consuming raw oysters. 

The Food and Drug Administration (FDA) has collaborated with the 
Interstate Shellfish Sanitation Conference (ISSC) for years to reduce 
V. vulnificus illness through improving consumer education and 
refrigeration practices, but these practices have failed to achieve 
measurable reductions of V. vulnificus illnesses nationally. FDA has 
proposed the implementation of PHP, or other equivalent controls, to 
substantially reduce V. vulnificus illness, but the Gulf Coast 
industry, state officials, and elected representatives have raised 
concerns about implementing PHP controls. FDA has considered these 
concerns and recognizes the need to further examine the timing and 
processes for oyster harvesters to gain access to PHP facilities or 
equivalent controls. To that end, FDA commissioned an independent 
study to assess how PHP or other equivalent controls can be 
implemented in a safe, efficient, and economic manner and will be 
addressing the concerns related to that study raised by GAO in an 
addendum to that study. FDA will continue to collaborate and dialog 
with industry, state officials, and the ISSC to explore reasonable and 
workable approaches to substantially reduce V. vulnificus illness and 
protect the American people from this painful, deadly and preventable 
disease. 

FDA's responses to GAO's recommendation are set forth below: 

GAO Recommendations: 

To better ensure the safety of oysters from the Gulf of Mexico that 
are sold for raw consumption, we recommend that the Commissioner of 
FDA work with the Executive Board of the ISSC to take the following 
four actions: 

* agree on a nationwide goal for reducing the number of V. vulnificus 
illnesses caused by the consumption of Gulf Coast raw oysters and 
develop strategies to achieve that goal, recognizing that consumer 
education and time and temperature controls have not resulted in 
achievement of the 60 percent V. vulnificus illness rate reduction 
goal and that the capacity to use post-harvest processing (PHP) on 
Gulf Coast oysters harvested from April through October that are 
intended for raw consumption does not currently exist; 

FDA Response: 

The ISSC has attempted to achieve the 60% illness reduction goal that 
had been established in 2001 through improved refrigeration practices, 
limited PHP and consumer education, but these efforts have not 
succeeded. FDA recognizes the efforts that went into these 
undertakings and will continue to collaborate with the ISSC to find 
strategies and explore approaches to establishing reasonable and 
workable goals for reducing V. vulnificus illness and protecting 
Americans from this deadly and preventable disease. As FDA continues 
in these efforts the agency remains mindful that effective 
technologies have been developed that can largely eliminate the hazard 
of V. vulnificus while producing oysters that retain the sensory 
qualities of untreated product. 

* correct the limitations in the current approach to measuring 
progress toward the 60 percent V. vulnificus illness rate reduction 
goal or design and implement a new approach that does not have the 
limitations of the current one; 

FDA Response: 

FDA agrees that the current approach used by the ISSC to count V. 
vulnificus illnesses and assess illness rate reduction is defective 
and should be corrected. The evaluation of success of existing control 
measures is based on counting illnesses reported in four "core" states 
(CA, LA, TX, FL). For a number of years, FDA has advised the ISSC of 
concerns with that approach. While the ISSC has claimed some success 
in its effort to reduce V. vulnificus illnesses, using numbers for the 
four "core" states, the rate of illness at the national level has 
remained relatively static. Much of the success claimed by the ISSC is 
directly attributable to the 2003 California ban on raw, untreated 
Gulf oysters. That ban virtually eliminated oyster associated V. 
vulnificus illnesses in California, which previously reported 5 to 6 
annually. Continued use of California as a "core" state in the ISSC's 
illness counting system biases the calculated illness reduction rate. 
Even if the ISSC's 60% goal had been achieved, it is unlikely that a 
measurable reduction in the rate of illness nationally would have been 
realized. This presented itself as a significant factor in FDA's 
announcement of its intent to revise its policy and issue guidance 
regarding PHP. FDA wishes to continue working with the ISSC to develop 
a counting formula that accounts for illness nationally and that 
realistically defines how effective V. vulnificus control measures 
are, whatever they include. 

* regularly evaluate the effectiveness of V. vulnificus illness 
reduction strategies, such as consumer education and time and 
temperature controls, to determine whether they are successful and 
should be continued or are ineffective and should be stopped; 

FDA Response: 

FDA agrees with GAO that the approach that has been used to evaluate 
the effectiveness of illness reduction strategies has limitations that 
undermine its credibility, including the limited number of states used 
in determining V. vulnificus illness reduction, and the overstatement 
of the effectiveness of the primary V. vulnificus illness reduction 
strategies, consumer education and time and temperature controls—-by 
including V. vulnificus illness data from California. 

Historically FDA, ISSC and the States have devoted significant 
resources to conducting V. vulnificus education campaigns. Directed at 
the consuming public, these activities have been aimed at informing at-
risk consumers about the risks of consuming raw molluscan shellfish. 
Campaign efforts have also targeted health professionals who provide 
care to at risk individuals, including those with underlying medical 
conditions, such as liver disease and chronic alcohol abuse While FDA 
has not undertaken a study to specifically examine the impact of 
educational programs, there is no indication that they have resulted 
in any substantial reduction in the occurrence of V. vulnificus 
illnesses, as evidenced by the relatively static level of illnesses 
and deaths occurring each year nationally. A survey commissioned by 
the ISSC in 2004 does not suggest a reduction in the number of at-risk 
consumers who are consuming raw oysters and there is no evidence of 
illness reduction at the national level. Furthermore, even though the 
independent impact of education on the rate of illness cannot be 
measured, the impact appears to be marginal at best given that the 
current illness reduction rate (based on 2009 and 2010 data) is only 
38.8% in the "core' states. That rate of reduction is significantly 
skewed by the use of California as a counting state. FDA has concluded 
that additional efforts to educate will have little if any beneficial 
outcome. 

With regard to assessing the effectiveness of existing controls on 
illness reduction, it is extremely difficult, and perhaps impossible, 
to tease out the contribution of one control measure versus another. 
For that reason, ISSC goals have relied on illness counting to 
determine their success. Unfortunately, the counting strategy employed 
by the ISSC is flawed, for reasons previously discussed and pointed 
out by GAO. Studies to compare V. vulnificus levels in retail oysters 
subsequent to states' implementation of time and temperature controls 
to levels found in previous retail studies may help identify levels of 
consumer exposure. However, FDA has no plans to conduct additional 
studies given existing budgetary and competing priority 
considerations. One thing that remains clear is implementation of 
strict time and temperature controls by states has not achieved the 
ISSC 60% illness rate reduction goal. Nor have these controls resulted 
in any illness reduction at the national level. Arguments have been 
put forth suggesting that industry compliance is problematic and that 
increased effort by states and FDA to enforce compliance is needed. 
Toward that end, FDA is moving from biennial to annual evaluation of 
V. vulnificus control plans being used by states and industry. As part 
of its increased compliance evaluation, FDA will conduct annual onsite 
checks at oyster landing sites and processing plants to examine 
compliance with V. vulnificus HACCP controls, harvester records, 
time/temperature logs, and actual product temperatures. Such efforts 
will help address concerns that the goal has not been met due to 
inadequate implementation and enforcement of controls. 

* conduct further study of the six issues of concern that we 
identified regarding the RTI report's economic analysis to ensure a 
more accurate assessment of the feasibility of developing adequate 
capacity and before FDA and the ISSC move forward with revising the 
National Shellfish Sanitation Program's shellfish safety guidelines to 
provide postharvest processing for oysters harvested from Gulf Coast 
waters during warmer months and intended for raw consumption. 

FDA Response: 

The 6 issues of concern identified by GAO are as follows: 

* Baseline data may not be representative of industry; 

FDA disagrees with the argument that baseline data, upon which the 
study is premised, is not representative. Data for 2008 are 
representative of a typical year, in which natural or manmade 
disasters are not of impact. As such, 2008 serves well as a baseline 
for what a "normal" year in the Gulf historically represents. Use of 
data for 2010 would not have represented a typical harvest year due to 
the Gulf oil spill disaster that reduced harvest levels due to 
closures in many Gulf Coast harvest areas. This circumstance would 
have skewed the results, possibly underestimating the impact and cost 
associated with PHP. Furthermore, to have waited until more recent 
data was available, and for what would be representative of a "normal" 
year, would have delayed efforts by FDA to examine the feasibility of 
PHP. Moreover, according to RTI, the overall conclusions of their 
study likely would not have changed. 

* Key costs are excluded; 

FDA recognizes that exclusion of certain costs can and have affected 
final cost outcomes presented in the RTI report. In an effort to 
better assess how costs associated with needs such as land purchase, 
new facility construction, transportation, and insurance, FDA has 
commissioned additional work to address these cost considerations. 

* Who should pay to expand processing capacity is not clear;
FDA recognizes the importance to industry of identifying financing 
opportunities to consider and tap to partially defray the costs of 
implementing the PHP. FDA has commissioned additional analysis to be 
performed by Research Triangle Institute to develop information to 
fill this gap. FDA does not consider identification of funding 
opportunities to be principally the responsibility of the Agency. 

* Limited support exists for estimated time frame for increasing post-
harvest processing capacity; 

The report presents what are considered minimum time frames for 
meeting the needed PHP capacity and its implementation. As a baseline 
minimum, it provides FDA with guidance on what the general time frame 
for full implementation may be. FDA recognizes that there may be 
additional time needs and constraints. The Agency stands ready to 
engage the industry and states in dialog regarding time frames. 

* Assumptions about post-harvest processing for oysters shipped within 
state borders are likely inaccurate; 

FDA and RTI recognize that the study did not consider the possibility 
of Gulf States allowing for the intrastate sale of untreated oysters. 
FDA has commissioned additional analysis to be performed by Research 
Triangle Institute to address this concern. It may be possible that 
analysis could be done to account for intrastate shipment and sale of 
oysters for raw half-shell consumption that have not undergone PHP. It 
may also be possible that costs could be recalculated assuming that 
private processors would only post-harvest process interstate half-
shell oyster shipments. In addition, the economic impact model used to 
assess the price and quantity effects of PHP requirements could be 
altered to assume that only interstate shipments of oysters intended 
for raw half-shell consumption would be post-harvest processed. It has 
been pointed out however, that to make these alterations to the model 
would require development of assumptions regarding numerous values in 
the model given the lack of data (e.g., estimates of the degree to 
which consumers in each of the Gulf states would substitute between 
oysters that have and have not been post-harvest processed). 

* Post-harvest processing costs may not be able to be passed on to 
consumers. 

PHP Gulf oysters are currently marketed at premium prices, according 
to the report. However, if PHP becomes the standard for Gulf oysters, 
the ability to gain premium prices to offset PHP processing costs 
becomes less likely. There are many uncertainties around the question 
of price. RTI indicated to FDA that, "If it is indeed the case that 
none of the costs of PHP could be passed along to consumers, an 
economic impact model is not an appropriate tool for assessing effects 
of the PHP requirements because the main purpose of this type of model 
is to determine the extent to which prices in the market would adjust 
to a change. In this case, the results of the economic impact model 
(Section 5.2 of the report) should simply be disregarded, and the 
closure analysis (Section 5.1 of the report), which includes estimates 
of the total costs of complying with PHP requirements, should be the 
focus of the economic analysis." 

[End of section] 

Appendix III: Comments from the Interstate Shellfish Sanitation 
Conference: 

ISSC: 
Interstate Shellfish Sanitation Conference: 
209-2 Dawson Road: 
Columbia, SC 29223: 
Phone: 803-788-7559: 
Fax: 803-788-7576: 
Email: issc@issc.org: 

August 22, 2011: 

Mr. Steve Secrist, Assistant Director: 
United States Government Accountability Office: 
Natural Resources & Environment: 
Western Region, San Francisco Office: 
301 Howard Street, Suite 1200: 
San Francisco, CA 94105: 

Dear Mr. Secrist: 

Thank you for providing the Interstate Shellfish Sanitation Conference 
(ISSC) an opportunity to review and comment on your draft report 
entitled, Food Safety: FDA Needs to Reassess Its Approach to Reducing 
an Illness Caused by Eating Raw Oysters (GAO-11-607). 

The Executive Board of the ISSC has reviewed the report and their 
comments have been incorporated into the attached document. FDA has a 
representative on the Executive Board; however the agency did not 
participate in this ISSC review. The report focuses on ISSC efforts to 
reduce Vibrio vulnificus (Vv) related illnesses and deaths. The 
comments are formatted consistent with the draft report. 

The ISSC is in general agreement with the recommendations of your 
report. However, the scope of your investigation did not allow for a 
review of the history of involvement by ISSC and FDA on this issue. 
The scope did not allow for a full explanation of the many issues 
associated with Vv that makes this problem very unique. Regardless, we 
will continue to work with FDA to develop risk-based, cost effective 
ways to improve the safety of raw molluscan shellfish. We continue to 
be committed to reducing illness associated with Vv and will continue 
our efforts to explore cost effective appropriate measures which can 
be implemented to address illnesses associated with this naturally 
occurring Vibrio. 

The ISSC Executive Board and membership appreciates your efforts in 
preparation and communication in the development of this report. Your 
efforts were thorough and the depth of knowledge obtained by your 
staff is to be commended. Should you have any questions on comments 
regarding this response, please contact Ken B. Moore, ISSC Executive 
Director or me at (508) 990-2860 extension 122. 

Sincerely, 

Signed by: 

J. Michael Hickey, Chairman: 
ISSC Executive Board: 

cc: ISSC Executive Board Members: 
Ken B. Moore, Executive Director: 
ISSC Vibrio Management Committee Members: 

[End of letter] 

Interstate Shellfish Sanitation Conference Comments On The Government 
Accountability Office Draft Report: 

Food Safety: FDA Needs to Reassess Its Approach to Reducing an Illness 
Caused by Eating Raw Oysters GA0-11-607: 

The Interstate Shellfish Sanitation Conference (ISSC) welcomes and 
appreciates the opportunity to review and comment on the Government 
Accountability Office's (GAO) draft report. The ISSC is in general 
agreement with the four (4) recommendations of the report. Provided 
below are general comments and specific comments to the report. 

Background of ISSC: 

The National Shellfish Sanitation Program (NSSP) was developed in 1925 
when the U. S. Public Health Service responded to a request for 
assistance from local and state public health officials in controlling 
typhoid fever and other bacterial diseases associated with the 
consumption of raw molluscan shellfish (oysters, clams, and mussels). 

The public health control procedures established by the Public Health 
Service were dependent on the cooperative and voluntary efforts of 
State regulatory agencies. These efforts were augmented by the 
assistance and advice of the Public Health Service (now the Food and 
Drug Administration [FDA]) and the voluntary participation of the 
shellfish industry. These three parties combined to form a tripartite 
cooperative program. The guidelines of the program have evolved into 
the NSSP Guide for the Control of Molluscan Shellfish which is managed 
and updated by the ISSC. The cooperative nature of the NSSP allows FDA 
to administer a domestic and international program with a relatively 
small federal commitment. 

In the many years since its establishment, the program has proven to 
be effective in minimizing the reoccurrence of illness associated with 
bacterial pathogens originating from human waste. The NSSP has also 
responded and essentially eliminated the occurrence of illness from 
natural toxins associated with harmful algae blooms. The ISSC, NSSP, 
and FDA continue to face new challenges in assuring that molluscan 
shellfish are safe for human consumption. Naturally occurring 
pathogens, particularly Vibrio parahaemolyticus (Vp) and Vibrio 
vulnificus (Vv) is one of those challenges we must address. Our
commitment has not changed since 1925. The ISSC Vibrio Management 
Committee is aggressively pursuing effective and appropriate 
strategies that will address this food safety concern. 

General Comments: 

The ISSC applauds the effort of the GAO to examine the Vv problem. 
However, the scope of your investigation did not allow for a broader 
explanation of the uniqueness of the Vv issue. An understanding of the 
uniqueness is critical for a full understanding of the present 
controls that exist for addressing Vv illnesses. 

The controls which have been incorporated into the NSSP since 1987 to 
address Vv were developed by ISSC and supported by FDA. FDA was fully 
engaged in the development of many of the approaches. Together, we 
recognize the limited success of several of our programs. In the late 
1980s we agreed that with the small number of illnesses that physician 
and consumer education was more prudent than regulation. We now know 
that while education has benefits it will not significantly reduce 
national Vv illnesses. In 2001 we agreed that if the industry was 
allowed to process oysters to reduce Vv to non detectable levels and 
label the product safe that consumers would demand the safer product 
and the market place would encourage the industry to Post Harvest 
Process (PHP) oysters. This has not been the case. Consumer demand for 
PHP product has not created the financial incentive to encourage the 
majority of the industry to pursue PHP. 

Your report provides an accurate estimate of the prevalence of Vv 
illnesses which is approximately 32 illnesses per year. When compared 
to other food borne illnesses, this number is very small. This number 
has remained virtually unchanged since the early 1990s. During this 
period the number of reporting states has nearly doubled. The Centers 
for Disease Control and Prevention (CDC) reports that due to the 
severity of the illness, practically all cases are reported. The State 
Voting Delegates of ISSC, responsible for implementing controls in 
their respective States, have struggled to identify controls to 
address a naturally occurring organism that affects only 32 
individuals annually. It is also important to note that the general 
population is not at risk. 

Vv poses a risk to immuno-compromised individuals. Approximately 7% of 
the US population is immuno-compromised. Only a small number of that 
7% is affected. Most food safety concerns place all consumers at risk. 
States prioritize resources to address food safety issues which pose 
the greatest threat of illness to consumers. Implementing regulatory 
controls which cause industry financial hardship make regulating this 
problem very problematic. 

The inability to identify other food safety issues with similar 
illness burdens that have been regulated with similar costs to an 
industry has made consensus on this issue difficult. The cost benefit 
debate on Vv has always been an obstacle for the ISSC in agreeing on 
controls. Yet the ISSC has continued to be proactive in its efforts to 
reduce Vv illnesses. The report recommends that the ISSC and FDA agree 
on an appropriate Vv illness reduction goal. To accomplish this, ISSC 
and FDA must address the two broad questions: (1) what should be the 
goal of a public funded regulatory program for addressing a food 
safety issue which affects 32 persons annually; and (2) to what extent 
should a program of this type impose economic hardship to the industry. 

Your report outlines several areas of disagreement between the FDA and 
ISSC. There is agreement between FDA and ISSC in several areas that 
provide a foundation for identifying approach for addressing the 
problem. The FDA and ISSC agree that Vv illnesses pose a health risk 
which requires public health intervention. There is agreement on the 
scope of the problem and the ability of known controls to reduce risk. 
The only major disagreement is the extent of public health 
interventions that will appropriately address the problem. The extent 
of the interventions dictates the financial impact to the shellfish 
industry. The present controls adopted by the ISSC recognize a risk at 
harvest and are intended to minimize any increase in risk as a result 
of post harvest growth. Although these controls pose significant fiscal
challenges for the industry, states have imposed these controls. The 
FDA is proposing an approach requiring PHP, which would reduce the 
levels of Vv post harvest and further reduce the risk. While this
approach seems plausible it can not be implemented without financial 
devastation to the industry (see Research Triangle Institute (RTI) 
report). 

The FDA announced in 2009, intentions to reformulate policy to require 
post harvest processing or equivalent controls. This FDA announcement 
exacerbated the controversy associated with Vv controls. The 
cooperative nature of the NSSP requires support from all participants. 
The announcement of FDA was unilateral and has alienated the industry 
and states. Since the announcement FDA has been reluctant to engage in 
discussions regarding Vv goals and strategies to achieve those goals. 

It appears that all interested parties are fully engaged in the Vv 
issue but as you indicate in your report, we must work together to 
find agreement. The major challenge for FDA and ISSC is to find a 
middle ground approach that can be supported by all interested 
parties. It seems apparent from Congressional involvement on this 
issue that the members of Congress have a desire for mutual agreement 
on an acceptable risk for at-risk consumers choosing to eat raw 
molluscan shellfish. For that reason the ISSC firmly supports the 
recommendations of GAO. 

Specific Comments to the GAO Report: 

Page 2:
"The shellfish safety guidelines also included goals for reducing the 
rate of illness for four reporting states." 

ISSC Comments: 

The goal of the ISSC Vv Management Plan was to reduce illnesses 
nationally. The four (4) states of California, Florida, Louisiana, and 
Texas were used to measure effectiveness. These states were chosen 
because of their history in reporting Vv cases. 

Page 24:
"A senior FDA official told us that this motion is unlikely to be 
implemented in any meaningful way given limited state enforcement 
capacity." 

ISSC Comments: 

The FDA is responsible for ensuring compliance. The FDA should not 
have concurred with ISSC adoption of time temperature controls if 
there were concerns regarding implementation and compliance. The ISSC 
expects that the 2011 focused efforts of FDA to evaluate State 
compliance will result in effective implementation. 

[End of section] 

Appendix IV: GAO Contact and Staff Acknowledgments: 

GAO Contact: 

Lisa Shames, (202) 512-3841 or shamesl@gao.gov: 

Staff Acknowledgments: 

In addition to the contact named above, Stephen D. Secrist, Assistant 
Director; Leo G. Acosta, Analyst in Charge; Kevin Bray; Mark A. Braza; 
Allen T. Chan; Nancy L. Crothers; Barbara J. El Osta; Lorraine R. Ettaro; 
Mitchell B. Karpman; Anthony R. Padilla; Emmy L. Rhine; Anne O. Stevens; 
Kiki Theodoropoulos; and Nimish D. Verma made key contributions to this 
report. Also contributing to this report were Michael D. Derr, 
Katherine M. Raheb, and Jena Y. Sinkfield. 

[End of section] 

Footnotes: 

[1] The National Shellfish Sanitation Program is a federal/state 
cooperative program recognized by FDA and the ISSC for the sanitary 
control of shellfish (i.e., oysters, clams, mussels, and scallops) 
produced and sold for human consumption. States agree to have adequate 
laws and regulations to provide a legal basis within the state for 
sanitary control of interstate phases of the shellfish industry and 
certify that shippers of shellfish meet National Shellfish Sanitation 
Program standards. 

[2] Mississippi submitted its V. vulnificus risk management plan in 
2009 after it was determined that two or more confirmed cases of V. 
vulnificus consumption-related illnesses could be traced to the 
state's waters. 

[3] According to a senior ISSC official, the ISSC selected the four 
states to report V. vulnificus illness data because of the quality of 
their reporting systems--each had been consistently reporting V. 
vulnificus illnesses for the longest time period--and because most 
other states were not reporting V. vulnificus illnesses. 

[4] The ISSC calculates illness rate reduction as the change in the 
number of V. vulnificus illnesses per unit of population from baseline 
years 1995 through 1999. In those years, in the four states, there 
were 19.6 V. vulnificus illnesses and a population of 70,637,188, on 
average, resulting in an illness rate of 0.28 V. vulnificus illnesses 
per million people, according to ISSC data. In 2009 and 2010, there 
was a population of 85,419,577, on average, in the four states. 
Therefore, for example, to achieve the 60 percent illness rate 
reduction from the baseline years, the number of illnesses in the four 
states in 2009 and 2010 could not exceed 9.4 illnesses, on average. 

[5] We selected interviewees from attendees at a November 2010 
conference convening leading Vibrio researchers who had submitted 
research abstracts regarding the effect of temperature on V. 
vulnificus in Gulf Coast oysters and from referrals by FDA and state 
officials. 

[6] RTI is a leading research institute whose largest single field of 
study is health research. 

[7] Hemochromatosis causes the body to absorb too much iron from food. 
The excess iron is stored in organs, especially the liver, heart and 
pancreas, leading to life-threatening conditions such as cancer, heart 
problems, and liver disease. 

[8] Postharvest processing significantly reduces exposure to V. 
vulnificus bacteria by reducing it to nondetectable levels, which, as 
currently defined in the shellfish safety guidelines, would result in 
a reduction from the current average of 32 cases per year to 
approximately 1.2 cases per year, according to a 2005 report by the 
World Health Organization and Food and Agriculture Organization of the 
United Nations. Oyster harvest area closures essentially eliminate 
exposure to V. vulnificus bacteria because raw oysters could not be 
legally harvested from the closed areas. Shucking essentially 
eliminates exposure to V. vulnificus bacteria because shucked oysters 
are to be cooked before consumption, which destroys the V. vulnificus 
bacteria. 

[9] The V. vulnificus risk calculator is a tool that was designed by 
FDA for the states to use to predict the level of V. vulnificus 
illness rate reduction they could achieve as a result of different 
combinations of time and temperature controls. 

[10] RTI International, Analysis of How Post-harvest Processing 
Technologies for Controlling Vibrio vulnificus Can Be Implemented 
(Research Triangle Park, North Carolina: March 2011). 

[11] FDA's Hazard Analysis Critical Control Point system focuses on 
identifying and preventing hazards that could cause food-borne 
illnesses rather than relying on spot checks of manufacturing 
processes of finished seafood products to ensure safety. Processors 
are required to determine whether there are food safety hazards that 
are likely to occur and identify the preventive measures that can 
control those hazards by preventing, eliminating, or reducing them to 
an acceptable level. 

[12] According to the shellfish safety guidelines, the number of V. 
vulnificus illnesses in what the ISSC considers the four core 
reporting states--California, Florida, Louisiana, and Texas--is used 
to calculate illness rate reduction to determine if the 60 percent 
goal has been achieved. 

[13] GAO, Results-Oriented Government: Practices That Can Help Enhance 
and Sustain Collaboration among Federal Agencies, [hyperlink, 
http://www.gao.gov/products/GAO-06-15] (Washington, D.C.: Oct. 21, 
2005). 

[14] GAO, Managing For Results: Enhancing Agency Use of Performance 
Information for Management Decision Making, [hyperlink, 
http://www.gao.gov/products/GAO-05-927] (Washington, D.C.: Sept. 9, 
2005). 

[15] In our July 2001 report on shellfish safety, we recommended that 
FDA gather baseline data--such as the results of regular shellfish 
microbial tests--to facilitate evaluations of the effectiveness of 
shellfish safety programs. In response, FDA said it would review, in 
consultation with the ISSC, whether testing of shellfish meats should 
be added to the program. FDA decided not to implement the 
recommendation because it did not believe that its program could be 
improved by testing shellfish meats for contaminants. See GAO, Food 
Safety: Federal Oversight of Shellfish Safety Needs Improvement, 
[hyperlink, http://www.gao.gov/products/GAO-01-702] (Washington, D.C.: 
July 9, 2001). 

[16] See Cook et al., Vibrio vulnificus and Vibrio parahaemolyticus in 
U.S. Retail Shell Oysters: A National Survey from June 1998 to July 
1999, J. Food Prot. 65:79-87 (2002); and DePaola et al., Bacterial and 
Viral Pathogens in Live Oysters: 2007 United States Market Survey, 
Appl. Environ. Microbiol. 76:2754-2768 (2010). 

[17] The studies grouped the establishments into three types: (1) 
restaurants and "raw bars" where shellfish are opened on site for raw 
consumption; (2) seafood markets, including grocery stores, that offer 
oysters in the shell for retail sale; and (3) wholesale dealers 
selling oysters in the shell to the above establishments. The 2007 
study noted that these data near the point of consumption provide 
considerable insight on the level of protection provided by the 
current U.S. system of shellfish safety controls. It cautioned, 
however, that such data do not identify which aspects of the system 
(e.g., harvest, transportation, and retail) account for bacterial 
growth or die-off. 

[18] As noted in our 2009 seafood fraud report, seafood fraud can 
include a variety of illegal activities undertaken for economic gain. 
Such fraud typically involves mislabeling the seafood product by, for 
example, providing incorrect information about it. See GAO, Seafood 
Fraud: FDA Program Changes and Better Collaboration among Key Federal 
Agencies Could Improve Detection and Prevention, GAO-09-258 
(Washington, D.C.: Feb. 19, 2009). 

[19] This is for a 90 percent uncertainty interval. 

[20] In its report, RTI identified April through October as the warmer 
months. 

[21] According to the RTI report, it will take a minimum of 2 years to 
increase postharvest processing capacity at existing processing 
facilities and 3 years to develop centralized postharvest processing 
facilities for use by smaller oyster processors. 

[22] [hyperlink, http://www.gao.gov/products/GAO-01-702]. 

[23] La. Rev. Stat. § 56:437; Tex. Parks & Wild. Code. § 76.303. 

[24] Both WHO and FAO are located within the United Nations system. 
WHO is the directing and coordinating authority for health and is 
responsible, among other things, for providing leadership on global 
health matters, shaping the health research agenda, setting norms and 
standards, articulating evidence-based policy options, providing 
technical support to countries, and monitoring and assessing health 
trends. FAO serves both developed and developing countries by acting 
as a neutral forum where all nations meet as equals to negotiate 
agreements and debate policy and helps developing countries and 
countries in transition modernize and improve agriculture, forestry, 
and fisheries practices and ensure good nutrition for all. 

[25] The risk of illness represents the probability that an individual 
in the susceptible population will become ill from eating a serving of 
raw oysters. The estimated number of illnesses per 100,000 servings 
consumed by the susceptible population can be obtained by multiplying 
100,000 by the risk of illness per serving. Following the WHO/FAO risk 
assessment, the susceptible population includes people with certain 
medical conditions, including chronic liver disease, cancer, kidney 
disease, diabetes, and human immunodeficiency virus/acquired immune 
deficiency syndrome, who are at risk of developing a potentially fatal 
bloodstream infection known as septicemia. 

[26] World Health Organization and Food and Agriculture Organization 
of the United Nations, Risk Assessment of Vibrio Vulnificus in Raw 
Oysters: Interpretive Summary and Technical Report, Microbial Risk 
Assessment Series, 8 (Geneva, Switzerland and Rome, Italy: 2005). 

[27] For these two parameters in particular, we obtained from the FDA 
additional information that was consistent with but more detailed than 
the information reported in the WHO/FAO risk assessment. 

[28] Spring is defined as April, May, and June; summer is July, 
August, and September; fall is October, November, and December; and 
winter is January, February, and March. Although the difference in our 
estimates for winter is 42 percent, this represents a difference of 
about only one illness per 1 million oyster servings in absolute terms. 

[End of section] 

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