Lessons learned - according to the Produce Safety Project

A new report on the Salmonella Saintpaul investigation was released this week, and The Packer will have coverage of the issue in the Nov. 21 issue. The 32-page report was released by the Produce Safety Project, which is described as an initiative of The Pew Charitable Trusts at Georgetown University.

The report is characterized as an "in-depth review of the public record of last summer's Salmonella Saintpaul outbreak" A copy of the report and the executive summary can be found here.

From the executive summary:

For this report, PSP reviewed all of the public statements and Web site postings of the CDC and FDA; the transcripts of the FDA/CDC media calls; press releases and Web site postings by state public-health departments and industry trade associations; and media coverage from around thecountry. In addition PSP staff attended and monitored the oversight hearings held by Congressional committees. Based on that review, PSP calls on federal public-health officials to follow through on their commitment to undertake a thorough and comprehensive post-mortem analysis of the Salmonella Saintpaul outbreak and report their findingspublicly. The analysis should focus on:

• The need for preventive safety standards for fresh produce.

• Reforms needed to address organizational and capacity shortcomings in the public-health system’s response to foodborne-illness outbreaks at the local, state and federal levels.

• Procedures and systems needed to ensure accurate risk communication to the public and affected industries.

Preventive Safety Standards for Fresh Produce

FDA officials consistently pointed to this outbreak as further proof of the need for preventive safety controls forproduce but said they need Congress to act. In fact, FDA, under its existing statutory authorities, has established similar preventive control systems through its Hazard Analysis and Critical Control Point (HACCP) regulations for seafood and juice, and has proposed on-farm safety measures for shell eggs.5 Moreover, in early 2007, FDA officials cited those same existing statutory authorities when they unsuccessfully sought approval from the Department of Health and Human Services (HHS) to move forward on produce-safety tandards.6 The recent Salmonella Saintpaul outbreak shows the immediate need to establish preventive safety measures using existing legal authority.

Organization and Capacity

Questions about the food-safety system’s lack of organization,capacity and coordination and their resulting impact on the effectiveness of the public-health response are raised by comparing the CDC’s Mortality and Morbidity Weekly Report article7 on the outbreak (hereafter, “CDC Outbreak Report”) with the public statements of FDA and CDC officials during the outbreak. For instance, the epidemic curve (or “epi curve”) published in the CDC outbreak report shows that some 50 percent of the confirmed cases began before the FDA nationwide consumer advisory on June 7 recommending that consumers avoid eating certain tomatoes. While there was a drop in cases after that announcement, it appears that the most sustained drop began around June 24. Maybe this drop was a factor of the incubation period for the illness, or maybe it points to an off-target intervention. A post-mortem analysis should examine this question. In addition, the discussion in the CDC outbreak report of cluster investigations in mid- tolate-June raises questions about why FDA and CDC officials continued to maintain so steadfastly and for so long that tomatoes were the leading suspect for being the vector for Salmonella Saintpaul.

Risk Communications

From the beginning of the outbreak, public-health communication to the media and the public was disjointed and confusing. Five different agencies – two federal and three state –“announced” the outbreak over the course of four days with significant variations in facts and messages. Then, three weeks into the public-communications effort, the CDC significantly changed – with no explanation – the manner in which it presented outbreak data, from raw number of cases in a state, to cases per million in a state, to a range of cases per state. While the change in presentation of data by CDC may have been worthwhile, it begs the question of why established procedures were not in place before this outbreak began. These failures in communication may well have contributed to the public’s decision to stop buying and eating tomatoes altogether in June and July. To date, much of the analysis of the outbreak has focused on the “traceback,” FDA’s attempt to locate the source of contamination.8 As important as that discussion is, if the post-mortem analyses are limited to that aspect, deeper and even more fundamental structural and organizational shortcomings risk being neglected. Indeed, these shortcomings in the nation’s food-safety system are not new, having been documented repeatedly during the past decade by many expert bodies, including the National Academies of Science,9 the Government Accountability Office,10 and the FDA’s Science Board.11 The key question here is whether the nation’s food-safety policymakers will learn the lessons of this outbreak and fix the system. To learn those lessons, they need to undertake a thorough, in-depth and transparent review of what went right this past summer, what went wrong, what could be done better, and what should never happen again.

TK: Look for a timeline at the end of the report, which describes some of the communications from PMA and United during the outbreak investigation. It will be interesting to see how industry leaders weigh in on this report, but my first take is that is overly prescriptive; notably, of course, "preventive safety standards for fresh produce."