Food Safety: FDA Needs to Reassess Its Approach to Reducing an Illness Caused by Eating Raw Oysters
Published: 2011-09-08T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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.
section_title: What GAO Found
paragraphs: 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.
section_title: What GAO Recommends
paragraphs: 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.

section_title: Letter
paragraphs: 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. 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. 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—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. 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 app. I).  In addition, we interviewed a nonprobability sample of 11 leading Vibro  researchers about the scientific underpinnings of time and temperature  controls 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. 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.
subsections: section_title: Background
paragraphs: 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.
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.
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, 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.
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.
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.  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. 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.
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.
section_title: FDA and the ISSC Do Not Currently Agree on a V. Vulnificus Illness Reduction Goal
paragraphs: 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.
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.  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. 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.
section_title: The Approach FDA and the ISSC Use for Measuring Progress toward Their Illness Rate Reduction Goal Has Limitations That Undermine Its Credibility
paragraphs: 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.
section_title: FDA and the ISSC Have Taken Few Steps to Evaluate the Effectiveness of Consumer Education and Time and Temperature Controls
paragraphs: 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.
subsections: section_title: The ISSC Has Not Evaluated the Effectiveness of Consumer Education Efforts Since 2004, and FDA Has Not Conducted Its Own Evaluations
paragraphs: 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. 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.
section_title: FDA and the ISSC Have Not Directly Evaluated the Effectiveness of Time and Temperature Controls in Reducing V. Vulnificus Consumption-Related Illnesses
paragraphs: 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. 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. Those  studies surveyed the level of V. vulnificus bacteria and other pathogens in  oysters collected from both retail and wholesale establishments. 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.
section_title: Extent of Industry Compliance with Time and Temperature Controls Is Unknown
paragraphs: 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.
Harvester Information:  BOAT NAME/NUMBER: _____________________________________ HARVESTER NAME/ LICENSE NUMBER: _____________ __________________ DATE:___________ HARVESTER SIGNATURE: Molluscan  Shellfish  Harvested  for  Other  Than  Raw  (Half  Shell)  Consumption:  HARVESTING AREA/LEASE NO.: ____________________   PRODUCT INTENDED FOR OTHER THAN RAW CONSUMPTION:  (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: ______   TEMPERATURE  OF  COOLER  WHEN  UNLOADING  TIME WHEN LAST OYSTER FROM BOAT ARE PLACED IN  TEMPERATURE  OF  COOLER  WHEN  LAST  OYSTERS  FROM THE BOAT ARE PLACED IN COOLER: _______   ORIGINAL CERTIFIED DEALER SIGNATURE___________________   (OR AUTHORIZED REPRESENTATIVE)
DATE 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. 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.
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.
section_title: Extent of Illness Reduction from Time and Temperature Controls Depends on Compliance Levels
paragraphs: 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. 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.
section_title: Adequate Capacity Does Not Exist to Use Postharvest Processing on Gulf Coast Oysters, and Questions Exist about the Feasibility of Developing Such Capacity
paragraphs: 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. 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. 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.
subsections: section_title: RTI Report Finds Adequate Capacity Does Not Exist for Postharvest Processing without Additional or Expanded Facilities
paragraphs: 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.  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.
section_title: Six Issues of Concern Raise Questions about the Feasibility of Developing Adequate Postharvest Processing Capacity
paragraphs: 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. 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.
section_title: Conclusions
paragraphs: 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.
section_title: Recommendations for Executive Action
paragraphs: 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.
section_title: Agency Comments and Our Evaluation
paragraphs: 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 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.
section_title: Appendix I: Estimating the Impact of Time and Temperature Controls on the Number of Illnesses from V. Vulnificus
paragraphs: 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. 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.
subsections: section_title: The Structure of the WHO/FAO Risk Simulation Model
paragraphs: 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. The risk simulation model was presented in a WHO/FAO  report on the assessment of risk of V. vulnificus in raw oysters. 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.
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.
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. 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.
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.
section_title: Time and Temperature Controls for Florida, Louisiana, and Texas and Our Simulations of Various Compliance Rates with the Controls
paragraphs: 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.
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.
section_title: Estimates of the Number of V. Vulnificus Illnesses Using FDA’s Risk Calculator
paragraphs: 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.
section_title: Effect of Uncertainty and Compliance Rates on the Likely Impact of Time and Temperature Controls on the Number of V. Vulnificus Illnesses
paragraphs: 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.
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.
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.
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.
section_title: Appendix II: Comments from the Department of Health and Human Services
paragraphs: Appendix II: Comments from the Department  of Health and Human Services  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 dialogue 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,  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) 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;  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)
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 indentify 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.
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) 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 post- harvest 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.
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)
Limited support exists for estimated time frame for increasing post-harvest processing  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 dialogue regarding time frames.
Assumptions about post-harvest processing for oysters shipped within state borders are  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.”
section_title: Appendix III: Comments from the Interstate Shellfish Sanitation Conference
paragraphs: 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  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.
J. Michael Hickey, Chairman  ISSC Executive Board  cc:  ISSC Executive Board Members  Ken B. Moore, Executive Director  ISSC Vibrio Management Committee Members  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  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.
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 ) 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.
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. 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.
section_title: Appendix IV: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Staff Acknowledgments
paragraphs: 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.