Table 1 shows the time and temperature controls  implemented in Florida, Louisiana, and Texas on May 1, 2010. 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. FDA and the ISSC Do Not Currently Agree on a V. Vulnificus Illness Reduction Goal

In October 2009, a senior FDA official announced in a speech before the  ISSC that, under FDA’s Hazard Analysis and Critical Control Point rules,  beginning in May 2011, FDA intended to require postharvest processing  of all Gulf Coast oysters harvested during warmer months, when higher  levels of V. vulnificus are more likely to be present, to reduce V. vulnificus  to nondetectable levels. 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. The Approach FDA and the ISSC Use for Measuring Progress toward Their Illness Rate Reduction Goal Has Limitations That Undermine Its Credibility

The approach FDA and the ISSC have been using to measure progress  toward their 60 percent illness rate reduction goal established in 2001 has  three main limitations that undermine its credibility: the limited number of  states used in determining V. vulnificus illness reduction, overstatement  of the effectiveness of the primary V. vulnificus illness reduction  strategies, and not controlling for the effect of such factors as natural and  man-made disasters. 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. 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. 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. 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. 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 its response, FDA agreed with our recommendation,  and the ISSC agreed that it did not have a detailed plan to ensure  postharvest processing capacity. 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 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’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. 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. The four (4) states  of  California,  Florida,  Louisiana,  and  Texas  were  used  to  measure  effectiveness.
Why GAO Did This Study

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

What GAO Found

FDA and the ISSC do not agree on a common V. vulnificus illness reduction goal. In October 2009, FDA announced its intention to change its approach to V. vulnificus illnesses from reducing them to largely eliminating them. To do so, FDA would require states to use postharvest processing methods, which include a mild heat treatment known as low temperature pasteurization. FDA's announced approach was a change from the 60 percent illness rate reduction goal established by the ISSC in 2001, with FDA concurrence. In a November 2009 letter to FDA, the ISSC expressed disappointment that FDA had not followed a 1984 memorandum of understanding that calls for FDA and the ISSC to consult on such matters. If FDA and the ISSC are not in agreement on the illness reduction goal and strategies to achieve it, it will be difficult for the Gulf Coast states to move forward to significantly reduce the number of consumption-related V. vulnificus illnesses. The approach FDA and the ISSC have been using to measure progress toward the previously agreed upon V. vulnificus illness rate reduction goal established in 2001 has limitations that undermine its credibility. For example, the ISSC continues to include California's results in its illness rate reduction calculation along with Florida, Louisiana, and Texas. Doing so overstates the effectiveness of consumer education and time and temperature controls--FDA's and the ISSC's primary strategies for reducing V. vulnificus illnesses--because California, unlike these other states, requires that all raw Gulf Coast oysters harvested during the summer and sold in the state be processed to reduce V. vulnificus to nondetectable levels, which has reduced V. vulnificus illnesses to nearly zero. FDA and the ISSC have taken few steps to evaluate the effectiveness of their consumer education efforts since 2004. Likewise, they have not directly evaluated the effectiveness of the time and temperature controls implemented in 2010, which call for harvesters to ensure that oysters are cooled to specific temperatures within certain times to reduce V. vulnificus growth. Although data are not available, our discussions with state and oyster industry officials suggest 100 percent compliance with the controls is highly unlikely. Moreover, our analysis shows--even assuming 80 percent compliance in the summer months-- it is unlikely that these controls will lead to the level of illness reduction estimated by a model developed by FDA. The Gulf Coast oyster industry does not have sufficient capacity to process all of its oysters intended for raw consumption that are harvested from April through October to reduce V. vulnificus to nondetectable levels, according to an FDA-commissioned report. The report concluded that it will take a minimum of 2 to 3 years to develop the infrastructure needed to process these oysters. However, the report has some limitations that call into question the completeness of its cost and timeline estimates. For example, the report's cost estimates did not include some construction costs and costs associated with purchasing land needed to expand existing processing facilities or build new ones. Without this information, the full cost of developing sufficient processing capacity will not be known.

What GAO Recommends

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