E. coli O157:H7 Cases Decline In 2009, Meeting 2010 Healthy People Goals

According to the CDC, incidence rates of E. coli O157:H7 decreased significantly in 2009 from recent averages, reaching the lowest level since 2004.

Moreover, for the first time, the number of reported cases actually fell below the federal 2010 Healthy People target of less than one case per 100,000 people.

As explained by Dr. David Goldman, assistant administrator of the FSIS Office of Public Health Science, the report “confirms our success in combating food-borne illness by setting an aggressive goal, designing an effective system to meet that goal, and [then] relentlessly implementing it.”

The most recent food-borne illness incidence data was collected and analyzed through FoodNet, a collaborative project including the CDC, USDA, FDA and various state health departments. FoodNet conducts active surveillance for nine pathogens, including Campylobacter, Cryptosporidium, Cyclospora, E. coli O157:H7, Listeria, Salmonella, Shigella, Vibrio and Yersinia. Click on the following link to learn how food-borne illnesses are tracked.

According to Dr. Chris Braden of the CDC, "the report indicates that there have been reductions in illness caused by many of these pathogens." Braden further explained that, “since FoodNet began surveillance in 1996, . . . [most] of the pathogens that we track have all declined."

And, while E. coli O157:H7 and shigella cases showed encouraging recent declines, the federal targets for Campylobacter, Listeria, Salmonella and Vibrio have not yet been met. Vibrio infections, for instance, increased by 85 percent compared with the first three years of surveillance, and Salmonella fell short of the goal.

Many Vibrio infections result from eating raw or undercooked shellfish, especially oysters. In turn, Salmonella is often difficult to combat because it can originate and spread from a wide variety of foods and environmental sources. In addition to foods, Salmonella has been associated with animals like baby chicks, small turtles, reptiles and frogs. And, as noted, while incidence levels for campylobacter and listeria continued to decline significantly, they still did not meet "Healthy People" targets.

In addition to the expected Senate passage of the Food Safety Modernization Act next month, the FDA is also moving forward with additional food safety initiatives aimed at decreasing food-borne illness. Dr. Jeff Farrar, the FDA’s associate commissioner for food protection, noted that the agency is still pursuing new requirements aimed at reducing the incidence of Salmonella during shell egg production. These initiatives are expected to become effective this summer, while FDA also works to develop a proposed rule which will likely include risk-based safety standards for produce.

If we are really serious about reducing food-borne illness, however, such initiatives and regulations are only one part of the overall equation. Much greater progress can likely be achieved – more quickly – if more consumers recognize the importance of properly handling and preparing raw animal foods. If all consumers can be educated to assume raw chicken, meat and eggs carry bacteria that can cause illness, to take additional precautions to avoid cross-contamination, and to cook all raw animal products to a safe temperature, consumers can significantly reduce their risk of becoming ill.

In this regard, better “Educated People” will more quickly and readily translate into far more “Healthy People.”

Are Food-Borne Illnesses Declining, Increasing Or Holding Firm?

The answer, I suppose, depends upon who you ask.

With increased population, improved governmental outbreak surveillance, expanding media coverage, more public awareness, better attentiveness by healthcare professionals and increased frequency (along with substantial improvements) in testing, we might be justified to expect that the numbers of confirmed food-borne illnesses would be climbing like an uncontrolled fever. Nevertheless, according to a recent report issued by the CDC, the incidence of food-borne illnesses over the last three years has actually hit a “plateau.”

The findings are from 2008 data reported by FoodNet, a collaborative project of CDC, FSIS, the FDA and 10 separate states. Click on the following link for a copy of the CDC Report. According to CDC findings, incidence rates in 2008 for Campylobacter, Listeria, E. coli O157:H7, Salmonella, Shigella and other pathogens did not change significantly when compared to the previous three years (2005-2007). Moreover, significant declines since 1996 were reported in the incidence rates involving numerous, other food-borne infections.

Despite these findings, Robert Tauxe, deputy director of CDC's Division of Food-borne, Bacterial and Mycotic Diseases, suggested that we may have “reached a plateau in the prevention of food-borne disease.” In turn, David Goldman, assistant administrator of FSIS, indicated he was “concerned about the lack of progress in reducing the incidence of food-borne illness."  Click on the following link to learn how food-borne illnesses are tracked.

Has prevention really hit a plateau? Or, could the total number of illnesses be falling? Despite dozens of feverish outbreaks (and thousands of reported illnesses) recently associated with a long list of previously never-mentioned foods (such as produce, pot pies and peanut butter), the numbers of most food-borne illnesses (according to the CDC) have been holding firm. Although it might be easy to interpret such studies at face value, the real answer (lurking somewhere in the report’s constituent ingredients) might be far more complex.

Many will admit that, in years past, given considerable limitations in surveillance, testing and reporting, a large percentage of total illnesses simply went unreported. Given better public awareness and recent strides in our ability to detect and identify a greater number of food-borne illnesses and outbreaks, the lack of any perceivable increase in the CDC numbers could actually – in my humble view – represent a decline in total cases.

So, are food-borne illnesses declining, increasing or holding firm? While I doubt (and, there is no evidence) that the incidence rates for food-borne illness are on the rise, there are plenty of reasons to believe that we may have started – at the very least – to get this fever under control.

The 2008-2009 Salmonella Outbreak: An Overview Of The Investigation And Precautionary Recalls

Beginning in August and September 2008, a few, sporadic cases of Salmonella Typhimurium started to appear on the CDC PulseNet radar screen.  This was not unexpected, as numerous cases will exist at any given time throughout any given year. Through October and November 2008, however, the number of cases believed to be associated with this pathogen began to increase. Using Pulse-Field Gel Electrophoresis (“PFGE”) testing of culture-confirmed isolates (taken from various stool samples), the CDC determined that many of the newly-reported cases appeared to be related. In turn, these findings led to the first national case-control study, conducted on January 3 and 4, 2009, associated with the outbreak (learn how food-borne outbreaks are tracked).

According to the CDC, preliminary analysis of the study led investigators to suspect that peanut butter was a likely source of the outbreak. Following the preliminary findings, the Minnesota Department of Agriculture then began testing various peanut butter products, and eventually reported it had isolated the outbreak strain from an open 5-pound container of King Nut creamy peanut butter.  On January 10, 2009, after test results were shared with King Nut, it immediately initiated the first voluntary recall of peanut butter in the investigation.  Soon thereafter, the Connecticut Department of Public Health reported that it had isolated salmonella from an unopened 5-pound container of King Nut peanut butter. According to officials in Connecticut, the salmonella found in the container also appeared, by PFGE, to match the outbreak strain.   

Relying on trace-back efforts, investigators discovered that the King Nut peanut butter at issue was manufactured by the Peanut Corporation of America (PCA) in Blakely, Georgia. These preliminary findings prompted PCA, on January 13, 2009, to initiate the second voluntarily recall in the investigation - this recall included various peanut butter and paste products produced at the facility after July 1, 2008 (as additional information was developed and shared by investigators, this initial recall was later expanded on two occasions). Although these products were not sold directly to consumers, they had been distributed to numerous institutions, food service providers, food manufacturers and distributors.  In turn, because some of these products were also reportedly used, in part, as ingredients in other products (including cookies, crackers, cereal, candy, ice cream, pet treats, and other foods), additional precautionary recalls followed.  The following list outlines the progression of the subsequent voluntary and precautionary recalls (and, some expanded recalls), as industry worked very closely with the CDC and FDA to determine what raw materials and products could potentially be affected:

Friday, January 16, 2009:  

Saturday, January 17, 2009:

Sunday, January 18, 2009:

Monday, January 19, 2009:

Tuesday, January 20, 2009:

Wednesday, January 21, 2009:

Thursday, January 22, 2009:

Friday, January 23, 2009:

Saturday, January 24, 2009:

Although the list of precautionary recalls has been extensive (and could still increase as new information is discovered and shared by investigators), it is important to recognize that all of the recalls were voluntary, and most were precautionary. Although many of the recalled products likely did not carry the bacteria at issue, most recalls were nevertheless announced in an abundance of caution because, at the very least, the possibility was there. Additionally, as to those samples in which the pathogen was isolated, there is a good chance that the bacteria was not evenly distributed; thus impacting only limited products, but not others. For this reason, all parties will need to wait for the investigation to conclude to determine whether only a very few or potentially more of these products actually carried trace elements of the pathogen at issue.

Additionally, as an aside, you may recall that we reported (early on) that at least one American staple - Girl Scout Cookies - was not in any way associated with the ongoing outbreak and recalls.  To learn more about additional products not implicated, please visit the American Peanut Council, which has published a (still growing) list of peanut butter products and brands NOT affected in any way be the current recall.   

In the coming days, we will of course continue to watch and report as this investigation winds down.  We anticipate this will likely be soon, as illnesses associated with the outbreak appear, at this point, to be declining.  For this and many other reasons, we also once again express our gratitude to both industry and public health officials, scattered throughout the country, working collectively to bring this outbreak and investigation to its closure.  
 

Chapter 2: Understanding How Food-borne Illnesses Are Tracked

 

In addition to understanding how our food is regulated, it is absolutely critical, when faced with a potential food-borne illness claim, to understand and appreciate how food-borne illnesses are identified, investigated and confirmed by relevant governmental public health agencies. Without this information, it will be virtually impossible to adequately defend any food-borne illness claim.

Indeed, to gain a better understanding of the extent of food-borne illness in America, the federal government in recent years has developed comprehensive initiatives to help federal, state and local governments identify, track and solve food-borne illness cases. In 1993, for instance, a large outbreak of food-borne illness caused by E. coli O157:H7 sickened more than a hundred people in the western United States. In this outbreak, pulsed-field gel electrophoresis (“PFGE”) was used to determine the source of the outbreak by matching the DNA of the implicated E. coli to hamburgers from a national restaurant chain.

PulseNet

In the years that followed the 1993 multi-state E. coli O157:H7 outbreak, numerous surveillance programs increased the federal government’s ability to detect food-borne illness cases on a national scale. Following the 1993 outbreaks, for example, the CDC created PulseNet so that scientists and public health laboratories throughout the country could upload and then rapidly compare the PFGE patterns of bacteria isolated from ill persons.

From 195 PFGE patterns in the mid-1990s, the database has grown to over 120,000 patterns today. All 50 state public health departments participate in PulseNet, along with several local public health laboratories and the USDA and FDA. PulseNet Canada and PulseNet USA exchange DNA fingerprints and associated information in real time. Having real-time access to such information has helped investigators determine: (1) whether reported food-borne illness cases are genetically similar; and (2) whether they likely originated from a common source. Today, PulseNet links the CDC, state health departments, and food regulatory agencies so that multi-state outbreaks can be rapidly detected and investigated.

Bacterial pathogens analyzed include E. coli O157:H7, Listeria, Salmonella and other food-borne bacteria. When a PulseNet participating laboratory logs on to the PulseNet server, it will display a “recent match” message if two or more laboratories submit identical or closely related patterns within a specified time. A universal naming system was developed to help compare and interpret molecular subtyping information, using a 10-character code: XXXYYY.0000. The first three characters represent the bacterial pathogen, the next three denote the enzyme used for DNA restriction, and the last four characters represent the pattern designation. For example, in the pattern EXHA26.0026, EXH represents E. coli O157:H7, A26 represents restriction endonuclease AvrII, and 0026 is the pattern number.

OutbreakNet

Once a cluster of illnesses is identified that share a common PFGE pattern, epidemiologists interview patients in an effort to find or exclude a common source. Sources might be food, environmental elements or another person carrying and shedding the bacteria. The Outbreak Network for Food-borne Diseases Surveillance and Response, “OutbreakNet,” is a network of public health epidemiologists at the local, state and federal level who investigate food-borne and diarrheal disease outbreaks. OutbreakNet participants use standardized interview methods and forms, seeking to assess whether there are statistically significant common exposures among the patients. Information is shared rapidly via email, conference calls and website postings, and updated constantly during outbreaks so that if a common source can be identified, corrective action can be taken to minimize further illnesses.

An example of multi-state sharing among epidemiologists is this email from a recent outbreak suspected to be associated with ground beef:

 

 

FoodNet

The third part of the CDC surveillance network is The Food-borne Diseases Active Surveillance Network, “FoodNet,” which compiles evidence to draw broader conclusions about the extent of food-borne illnesses. FoodNet is a collaborative project of the CDC, 10 states (California, Colorado, Connecticut, Georgia, Maryland, Minnesota, New Mexico, New York, Oregon and Tennessee), the USDA, and the FDA. This network collects data regarding diseases caused by enteric pathogens transmitted commonly through food. FoodNet staff routinely contact all clinical laboratories in the 10 FoodNet sites to collect information on every laboratory-confirmed case under surveillance. FoodNet surveillance in the 10 participating states includes nearly 45 million people, or approximately 15% of the United States’ population. For 2006, FoodNet reported rates of infection per 100,000 people as follows:

  1. Salmonella:  14.81
  2. Campylobacter: 12.71
  3. Shigella: 6.09
  4. Cryptosporidium: 1.91
  5. E. coli O157:H7: 1.31
  6. non-O157:H7 STEC: .46
  7. Yersinia: .35
  8. Vibrio: .34
  9. Listeria: .31
  10. Clycolspora: .09

FoodNet also estimates the burden and trends over time for food-borne infections, and conducts studies to better understand the epidemiology of food-borne diseases. Its goal is to develop better prevention strategies at each step of the farm-to-table continuum so as to reduce the burden of food-borne illness. Proper handling at each step, including food preparation, is always stressed.

Aided by new initiatives such as PulseNet, OutbreakNet and FoodNet, the CDC estimates that, annually, nearly 76 million people continue to be affected by some type of food-borne illness. Of these, more than 300,000 are hospitalized and about 6,000 people die. Although most people affected by food-borne illness develop only mild symptoms (or remain asymptomatic), food-born illness can cause greater concern for those with compromised or weakened immune systems, such as the very young or old. Because food-borne pathogens continue to exist naturally in many raw foods such as raw meat and poultry, and because there is no technology to eliminate them during production (with the exception, of course, of irradiation or cooking), today’s challenges with respect to the food supply remain as real as they are complex. As consumers, we must individually take care to avoid the potential hazards associated with raw foods. As industry representatives, insurers and lawyers, we must remain cognizant of the role food-borne illness will likely continue to play in our professional disciplines.

In any event, as food safety lawyers, it is and will always remain critical to be intimately familiar with these and other surveillance programs, and to stay abreast of new developments.  Indeed, as surveillance continues to improve, the number of illness identified, and claims filed, will likely increase as well.

 

Copyright 2009 by Shawn K. Stevens