Pew report critiques Salmonella outbreak response

Nov 18, 2008 (CIDRAP News) – This past  summer's nationwide Salmonella Saintpaul outbreak exposed several gaps in the nation's food safety system, including poor organization and confusing risk communications, the Produce Safety Project (PSP), an initiative of the Pew Charitable Trusts, said in a report yesterday.

The authors of the 32-page report said in a press release that their goal was to frame questions for public health officials who will review the response to the outbreak, a probe that congressional leaders and produce industry representatives have requested. The PSP is based at Georgetown University in Washington, DC.

The outbreak, first reported in early June, sickened more than 1,400 people and badly hurt the fresh-tomato industry before authorities determined several weeks into the trace-back investigation that tainted jalapeno and Serrano peppers were the culprits.

The PSP's findings and recommendations are based on an extensive view of outbreak-related public records, including those of the Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and congressional hearings.

Jim O'Hara, director of the PSP, said in the statement that the problems identified in the report are nothing new. "Many of these problems have been identified for years by expert body after expert body," he said. "If we pass up this opportunity to learn from this most recent outbreak, we will keep repeating the same costly mistakes—for public health and industry alike."

Who has power to mandate produce safety?
During the outbreak, FDA officials said mandatory safety controls for produce were needed, but they were waiting on Congress to give them the authority. However, the PSP report says the FDA has used its existing statutory authority before to set Hazard Analysis and Critical Control Point (HACCP) regulations: in 1995 for seafood and in 2001 for juice. The report says the FDA has also proposed on-farm safety measures for shell eggs.

However, the document also notes that the FDA's attempts to enact produce safety regulations as part of its 2007 Food Protection Plan, using its existing authority, have been ignored by the Department of Health and Human Services (HHS).

At a House subcommittee hearing on the Salmonella outbreak in late July, David Acheson, MD, the FDA's associate commissioner of foods, said that the FDA, in proposing its Food Protection Plan last fall, asked for 10 specific legislative authorities, according to a previous report. Of those, "probably the one that's most important is the one that requires preventive controls [in food production and processing]. That's absolutely critical across the board," he said.

The PSP authors write, "The lack of federal action has resulted in a patchwork-quilt approach to fresh produce safety. Moreover, federal inaction may well be eroding public confidence in the safety of the food supply."

Problems with coordination and capacity
Another shortcoming that came to light was a lack of organization, capacity, and coordination that hurt the effectiveness of the outbreak response, the PSP authors report. They state that their review of the outbreak raises questions as to whether public health agencies shared data in a timely manner and whether poor communication between the agencies could have delayed the identification of peppers as the vehicle for Salmonella contamination.

Problems with coordination and capacity showed up in the CDC's epidemic curve ("epi curve"), the report maintains. When the FDA issued its nationwide advisory about tomatoes on Jun 7, officials originally reported that 145 people had been infected at that time, but the epi curve they issued later showed that more than 800 people—55% of the outbreak total—had illness onsets before that date. Also, the CDC acknowledged that the delays in reporting cases were a sign that response capacity was strained.

The epi curve showed a normal bell shape, which suggested that the FDA's interventions could have been too late or off target, the authors write.

According to the report, state public health departments acted quickly to respond and inform the CDC, but the CDC could have acted more quickly to inform the FDA, which is responsible for leading multi-agency and trace-back investigations. Also, big, multistate investigations such as the S Saintpaul outbreak reveal a disconnect between the epidemiological and trace-back efforts.

"Because these investigations are conducted by two separate agencies, they tend to be treated as separate processes rather than being seen as two sides of the same coin, needing significant integration," the report states.

Mixed and confusing messages
In reviewing the public health messages that came from various agencies during the outbreak, the authors concluded that messages were frequent but inconsistent, pointing toward a need for officials to establish risk-communication strategies before an outbreak occurs. For example, a lack of detail about early case clusters hampered the tomato industry's efforts to determine if there was a connection between illnesses and tomato distribution patterns.

As another example, the report says that the CDC changed the way it graphically portrayed outbreak information at several points during the outbreak. "It is troubling that this determination was not made beforehand; it might have minimized the confusion and frustration experienced by state officials, the produce industry, and consumers," it states.

O'Hara called on the incoming Obama administration to make mandatory, enforceable safety standards for fresh produce a food-safety priority and to take steps to fix the nation's broken outbreak response system. "Both actions will go a long way toward safeguarding public health and protecting farmers," he said.

See also:

Nov 17 Produce Safety Project press release

Nov 17 Produce Safety Project report
http://www.producesafetyproject.org/admin/assets/files/0015.pdf

Jul 31 CIDRAP News story "State models cited as ways to improve outbreak response"

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