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. 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. 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.