Full Disclosure: If you do not like lawyers, and according to most polls lawyers are less liked than members of Congress, your first thought might be that this op-ed’s purpose is to get public health to announce more outbreaks so I can get more work. That certainly might be a result of more robust disclosure, but believe me, with $100,000,000 worth of recent recent Listeria cantaloupe work, I will be just fine. However, I ask you for just a moment to put aside any anti-lawyer bias and answer a few critical questions with me:
1) Does the public have a right to know if a particular food product or its manufacturer have made people ill?
I would say yes. Most of us might vote with our pocketbooks, and not buy products from that manufacturer, unless we were sure they were safe.
2) Is public health served when foodborne pathogens are traced to their source?
I would say yes to that as well. Finding out how an outbreak happened gives us all the opportunity to learn how to lessen the chance of the same thing happening again.
The 2006 E. coli O157:H7 outbreak linked to Dole baby spinach was the known high-water mark for critical safety failures by leafy green growers and processors in Salinas, CA (1). Well over 200 confirmed illnesses nationally, five deaths, and dozens of cases of kidney failure were the coup-de-grace for a 10-year period that saw a litany of E. coli and Salmonella outbreaks linked to Salinas’s leafy greens.
But the spinach outbreak, and more specifically the painstaking investigation and analysis that followed, also marked the beginning of the end of full disclosure, and the beginning of, in some cases, complete silence by some state and federal public health officials about the details and even existence of foodborne illness outbreaks.
The 2006 spinach E. coli outbreak was, of course, a highly public event, no doubt requiring an open and frank discussion of the actions and failures that contributed to so many illnesses and deaths. Together with the Food and Drug Administration (FDA), California’s Food Emergency Response Team (CalFERT), which was a collection of epidemiologists and other scientists formed in 2005 to investigate outbreaks originating in California, produced a lengthy report discussing the trail of evidence that led to the conclusion that Dole’s baby spinach caused the outbreak, as well as the microbiological and environmental findings that gave some insight into the outbreak’s cause and likely source (2).
After the 2006 spinach outbreak — in fact, within three months of it — two more E. coli outbreaks, which sickened at least 152 people in six states, were linked to lettuce produced by California growers (3, 4). Again, CalFERT investigated the outbreaks and issued final reports, thereby providing both the industry and the public generally with information about the state of the industry in America’s salad bowl, and most importantly, the likely causes of the outbreaks.
But there the paper trail slowed.
Since the devastating fall of 2006 — three outbreaks; 404 illnesses; five deaths; dozens of cases of kidney failure — CalFERT has not issued a single report of its investigative activities, despite a leafy-green link to many more outbreaks. And, these are only the outbreaks that are known to have occurred.
Moreover, what can be pieced together based on limited responses to Freedom of Information requests, shows that the trend is not only limited to a lack of documented investigative conclusions about outbreaks, but also incomplete investigation of outbreaks, and increasing failures to notify the public at all that an outbreak has occurred. A few of the more known examples:
• September 2008 — at least 45 residents of Michigan, Illinois and Ontario, Canada were infected by E. coli-contaminated iceberg lettuce that was grown in California and processed at Aunt Mid’s Produce Company, a Detroit-area wholesale distributor. Again, neither the FDA nor CalFERT issued any kind of a summary report documenting their conclusions about the source or cause of the outbreak (5).
• April 2010 – at least 33 residents of Michigan, Ohio, Tennessee, Pennsylvania and New York were sickened by a relatively rare strain of E. coli called E. coli O145. Although this was the most publicized outbreak since the devastating fall of 2006, FDA refused to name the company that had grown the lettuce, instead choosing to identify only the state where the farm was located: Arizona. CalFERT was not involved in this investigation (6A, 6B).
• October 2011 – at least 60 people from 10 states were sickened by E. coli-contaminated romaine lettuce. Most of the ill were customers of Schnuck grocery stores in Missouri. Traceback investigation revealed both the processor of the contaminated lettuce and the grower, but again the FDA has declined to name either company (7).
A few of the lesser known, or not publicized, examples:
• May 2008 — at least 10 residents of Washington state were infected by E. coli-contaminated romaine lettuce grown and processed in Salinas, CA. Despite being involved in the investigation and product traceback to the lettuce processor, neither the FDA nor CalFERT documented their findings about the outbreak’s source or cause (8).
• October 2008 – at least 55 people in Canada, California, North Dakota, Illinois, Florida, New Jersey and Ohio were sickened by E. coli-contaminated romaine lettuce that had been grown in California. California and FDA investigation revealed that the implicated lettuce had been supplied to retail locations by a Salinas, CA company. Again, neither CalFERT nor the FDA issued a summary report about the outbreak (9).
• July/August 2009 – dozens of Oregon, Washington, Idaho, Colorado and Montana residents, and multiple Canadians, were sickened by Salmonella Typhimurium in an outbreak investigated by officials at the California Department of Public Health’s Food and Drug Branch. The contaminated lettuce was grown and processed in Salinas, CA, and despite clear epidemiological evidence implicating the lettuce, California officials declined to state a relationship between the implicated lettuce and the outbreak. Neither California nor the FDA issued a comprehensive report on the outbreak, nor was the implicated product ever recalled (10).
• September 2009 – at least 19 residents of Colorado, Utah, New York, South Dakota, Wisconsin and North Carolina were infected by E. coli-contaminated lettuce grown in Salinas, California. Again, neither CalFERT nor the FDA generated a report on outbreak findings (11).
• September 2009 – 10 individuals in 6 different states, Colorado, Connecticut, Iowa, Minnesota, Missouri and North Carolina suffered E. coli infections, sharing an indistinguishable PFGE pattern. The outbreak was identified by the CDC as cluster 0910MLEXH-1. Epidemiological investigations by multiple states strongly suggested lettuce as the source of the outbreak. The lettuce served at a Colorado restaurant, where both Colorado outbreak patients had consumed lettuce, was traced to a specific grower in California’s Salinas Valley. Colorado state health officials pushed for further federal agency effort but were rebuffed:
By mid-October, Colorado had not received any further communication from the CDC and FDA about the traceback, so Colorado made several inquiries about the status of the investigation. Investigators from the CDC reported that FDA had decided not to pursue further traceback activities because of limited resources and the length of time that had elapsed since the original exposures with no new cases. Colorado challenged this decision, but FDA
did not change its position (12).
Since the fall of 2006, and the media vortex that the three large E. coli outbreaks that occurred then created, the FDA and CalFERT have repeatedly failed to provide conclusions, and in some cases much information at all, about multiple major public health crises that have occurred in this country. This is a threat to the public’s health, which has as its only currency the free and rapid exchange of information.
Questions raised by FDA’s and CalFERT’S approach, or lack thereof, to providing information to the public about post-2006 leafy green outbreaks are many.
Is funding for public health programs lacking? Across the board, possibly, but CalFERT has not experienced any cuts to its operating budget; in fact, during this period, CalFERT has received a large grant from FDA.
If this is not a problem of funding, will CalFERT and FDA respond that they lack manpower? Unlikely, given the underlying reasons for the existence of CalFERT in the first place, which was a specific devotion of resources and highly competent public health officials to the problems emanating from Salinas Valley, and California generally.
There is no clear conclusion available from the known data as to why there is a lack of complete disclosure. Of course, there has been no explanation from these public health bodies regarding their reasons for the trend of non-disclosure.
Whatever the explanation, the lack of information about these outbreaks is far from simple instances of non-disclosure. Indeed, the path that CalFERT and FDA have chosen to take since the fall of 2006 threatens a general withdrawal from the obligations of open disclosure. And, this is only about the outbreaks that are known. There are likely many more that have occurred that have never seen the light of any disclosure at all.
2. For additional information on CalFERT, see the CalFERT poster as Attachment No. 3.
3. See 2006 Taco Bell investigation documents as Attachment No. 4.
5. See 2008 Aunt Mid’s trace back diagram as Attachment No. 8.
7. See 2011 Investigation Announcement: Multistate Outbreak of E. coli O157:H7 Infections Linked to Romaine Lettuce as Attachment No. 11.
8. See 2008 WA DOH investigation document as Attachment No. 12.
9. See 2008 CDPH and CDC documents as Attachment No. 13.
10. See 2009 Salmonella Typhimurium investigation summary as Attachment No. 14.
12. See April 30, 2010 Memorandum, Colorado Department of Public Health and Environment, Communicable Disease Epidemiology Program as Attachment No. 17.