One item in the consumer news wrap-up published by the Salt Lake Tribune yesterday caught our eye. It was this:

"A failure by government agencies to coordinate their investigation into a U.S. salmonella outbreak may have put the public at risk and caused needless harm to the tomato industry, according to the Produce Safety Project, an initiative of the Pew Charitable Trusts at Georgetown University. Salmonella sickened more than 1,400 people from April through August, with health officials initially citing tomatoes as a cause but later saying tainted jalapeno peppers were the key cause. Two federal agencies and three state agencies announced the outbreak of illnesses over four days "with significant variations in facts and messages," the report found.

We found the Produce Safety Project’s (PSP) website here and noted its key findings:

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 findings publicly.  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.

More from the report’s summary follows here.

 

 

 Preventive Safety Standards for Fresh Produce

FDA officials consistently pointed to this outbreak as further proof of the need for preventive safety controls for produce 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 standards.[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 article[7] 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- to late-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.

 

 

[1]Andrew C. Voetsch et al., "FoodNet Estimate of the Burden of Illness Caused by Nontyphoidal Salmonella Infections in the United States." Clinical Infectious Diseases 38, no. Suppl 3 (2004): S127-S134, here.

 

[2]U.S. Department of Health and Human Services, Food and Drug Administration, Agricola Zaragoza, Inc. Recalls Jalapeno Peppers Because of Possible Health Risk (July 21, 2008), here; FDA, FDA Extends Consumer Warning on Serrano Peppers from Mexico (July 30, 2008), here. 

[3]Reginald L. Brown testifying before the House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations, The Recent Salmonella Outbreak: Lessons Learned and Consequences to Industry and Public Health, 110th Cong. 2nd sess., July 31, 2008, here; "FDA tomato alert costly to Georgia producers" Southeast Farm Press, September 4, 2008, here.

[4]See, e.g., Edward Beckman testifying before the House Subcommittee on Oversight and Investigations, The Recent Salmonella Outbreak, 110th Cong. 2nd sess., July 31, 2008, here;  Statement of Rep. Bart Stupak, Chairman, Subcommittee on Oversight and Investigations, The Recent Salmonella Outbreak, 110th Cong. 2nd sess., July 31, 2008, here. 

[5]HHS, FDA, Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products, Final Rule, 60 Federal Register 65096 (December 18, 1995) (21 CFR Parts 123 and 1240); Hazard Analysis and Critical Control Point (HACCP), Procedures for the Safe and Sanitary Processing and Importing of Juice, Final Rule, 66 Federal Register 6137 (January 19, 2001) (21 CFR Part 120), here;  Prevention of Salmonella Enteritidis in Shell Eggs During Production, Proposed Rule,  69 Federal  Register 56823 (September 22, 2004), here. 

[6]FDA, "Fresh Produce Safety", Unpublished PowerPoint, (February 6, 2007).

[7]Centers for Disease Control and Prevention, "Outbreak of Salmonella Serotype Saintpaul Infections Associated with Multiple Raw Produce Items – United States, 2008," Morbidity and Mortality Weekly Report 57:no. 34(2008),here (hereinafter "CDC Outbreak Report").

[8]See, e.g., House Agriculture Committee, Subcommittee on Horticulture and Organic Agriculture, To review legal and technological capacity for full traceability in fresh produce,  110th Cong. 2nd sess., July 30, 2008, here.

[9]Institute of Medicine, National Research Council, Ensuring Safe Food From Production to Consumption, Washington D.C.: National Academy Press, 1998.

[10]Robert A. Robinson, Food Safety and Security: Fundamental Changes Needed to Ensure Safe Food, GAO-02-47T  (2001), here; Robert A. Robinson, Overseeing the U.S. Food Supply: Steps Should be Taken to Reduce Overlapping Inspections and Related Activities, GAO-05-549T (2005), here; GAO, High-Risk Series: An Update, GAO 07-310 (2007)26 here.

[11]HHS, FDA, Science Board to the FDA, Report of the Subcommittee on Science and Technology, FDA Science and Mission at Risk, (2007), 3, here.