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Food Safety News

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Publisher’s Platform: Public Disclosure and Public Health

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.

References:

1. See 2006 Dole-NSF investigation documents as Attachment No. 1 and No. 2.

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.

4. See 2006 Taco John’s investigation documents as Attachment No. 5, No. 6A, No. 6B and No. 7.

5. See 2008 Aunt Mid’s trace back diagram as Attachment No. 8.

6. See 2010 Freshway Foods investigation documents as Attachment No. 9 and No. 10.

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.

11. See 2009 Church Brothers investigation documents as Attachment No. 15 and No. 16.

12. See April 30, 2010 Memorandum, Colorado Department of Public Health and Environment, Communicable Disease Epidemiology Program as Attachment No. 17.

© Food Safety News
  • What I find particularly disturbing is the statement in Attachment #12, which reads:
    “…FDA had decided not to pursue further traceback activities because of limited resources…”
    While there were no new cases appearing, completion of the traceback could have provided valuable information and possibly prevented a new outbreak at a future date. What happened to “prevention”.
    For that matter, what happened to “Transparency?”

  • jmunsell

    Bill, in your question #2 above, you asked “Is public health served when foodborne pathogens are trace to their source”. Your answer was “Yes”. Well, USDA/FSIS disagrees with your conclusion. Consider these historical facts: the meat industry’s largest plants implemented HACCP on January 26, 1998. On October 8, 2010, FSIS issued Notice 58-10 which authorized its inspectors FOR THE FIRST TIME to document the origin of meat being sampled for E.coli O157:H7. It took the agency ten years and 9 months of hand wringing before it finally liberated its personnel to cooperate with food safety officials and epidemiologists. Such opposition to public health imperatives would be akin to telling FDA and CalFERT investigators that they are prevented from documenting source information, and that they are NOT to determine the source farm which produced contaminated produce.
    Let me show you how this works. On 3 consecutive days in February 2002, agency-conducted ground beef sampling at my plant produced 3 consecutive positives proving the existence of E.coli O157:H7. The two agency employees at my plant hand-wrote a statement in which they identified Est #969 in Greeley, CO as the source of all 3 positives. During the agency’s subsequent mishandling of this issue, FSIS informed me that I would have to implement corrective actions to prevent this from recurring again. I asked the agency what actions I could take to prevent the Greeley plant from ever again shipping me contaminated meat. The agency’s blithe response was “Discontinue purchasing from that plant, and buy from other sources”. The agency thus continued its policy to require the destination facility to make changes, while insulating the SOURCE plant from accountability, allowing the source plant to continue operations as is, with no corrective actions. I unsuccessfully argued with the agency that not requiring changes at the SOURCE virtually guarantees additional outbreaks. In spite of this no-brainer, FSIS adroitly avoided requiring the large source plant to implement corrective actions to prevent recurrences. Well, what happened? It should surprise no one that four months later, the Greeley plant announced a 19.1 million lb recall. Even the venerable USDA cannot indefinitely hide the truth.
    Since this agency debacle at my plant, I’ve visited with many other plant owners who have been involved in recalls. Again, it should be no surprise that most if not all of these owners related that FSIS repeated the same nonsense at their plants, in that the agency merely suggested that the downstream further processing plant purchase from other source supplier slaughter plants……..while not requiring any changes at the large source slaughter plant. Bill, this is one reason why I continue to state that pathogens are NOT the primary enemy of public health! Instead, gov agencies which refuse to force the source to clean up their act are the deadliest enemy consumers face in America……..and USDA’s inaction is funded by our tax dollars.
    Unfortunately, as your article states, other entities such as FDA & CalFERT seem to be cloning FSIS’s unwillingness to force the source, virtually guaranteeing additional future outbreaks.
    Are these gov entities being paid under the table to covertly cover up damaging evidence, the release of which would not only enable consumers to make intelligent choices of what to buy, but would also dramatically improve food safety? I don’t know. But obviously, something is fishy here.
    When Carl Custer (FSIS microbiologist) suggested to his employer in 2003 that the agency should traceback to the SOURCE, the agency’s reply was “We won’t be involved in witch hunts”. Interpretation: FSIS refuses to be involved in tracebacks to the source, because such tracebacks would in most cases end up at the doorstep of one of the large slaughter plants, which enjoy political clout and the financial wherewithal to tie the agency’s hands in court. The “witch” in such cases are large, frequently multi-national plants. FSIS is paralyzed with fear of litigation emanating from the large plants. Because of this litigation fear, FSIS allows the large source slaughter plants to continue operations “As Is”. FSIS prefers to remain out of court and depends on you to sue downstream further processing plants as though these downstream entities INTRODUCED pathogens. You are right that sickened consumers deserve financial reimbursement for their sicknesses, loss of wages, etc. Unfortunately, the middle man is increasingly paying the price for insanitary conditions existing at their source suppliers, primarily because we have a government staffed with cowards.
    Our government’s refusal to trace back to the source, to require the source to clean up its act, and apparent unwillingness to disclose evidence, prevents consumers from making intelligent decisions of what to buy, and what brands to avoid. Here again, the largest manufacturers benefit from disclosure. A case in point is the opposition against Country Of Origin Labeling laws by the largest food processors, especially from multinational food entities which have the ability to source food from around the globe. Although consumers have the right to know where their food originated, multinationalist companies cry foul, accusing consumerists with “Protectionism”, “Irrational Nationalism”, and “Artificial Trade Barriers”, all outlawed by the World Trade Organization, to whom America now bows. A superlative example is the decision by the WTO that USA’s country of origina labeling law is illegal, in litigation brought by Mexico & Canada. These two countries demand that their meat be able to course through our 50 states without being labeled as being of Mexican or Canadian origin. It should be no surprise then that FDA and CalFERT overtly oppose the disclosure of origin information of contaminated produce, because frankly, such disclosure is politically incorrect, as defined by the WTO.
    Bill, I respectfully suggest that corporations run the show in the food chain, effectively thwarting any government or consumerist attempt to disclosure the source. Threats of WTO legal sanctions provide additional impetus to gov entities to do nothing, wasting our tax dollars. While such inaction provides comfort to gov authorities, severe consumer health discomfort (sometimes death) rears its ugly head as the logical consequence of the government’s implementation of laissez faire deregulation of our food supply. FSIS has publicly stated that its HACCP program is based in science, which requires FSIS to no longer police the industry, allowing the industry to police itself. This heinous feint places pressure on FDA & CalFERT to likewise embrace a “Hands Off” non-involvement role.
    Two conclusions: (1) We direly need bold leaders in the government, who audaciously pursue the source, disclose the source, and boldly tell the large companies “see you in court”. (2) These recalcitrant government do-nothing folks should be sued, even more aggressively than downstream food companies victimized by purchasing previously-contaminated food. I hate to say this, but FDA, FSIS and CalFERT should suffer dramatic reductions in funding until they willingly agree to proactively pursue investigations to the source, with full disclosure. We may need to jettison all the leaders of these feckless gov agencies, and replace them with folks like Lee Iacoca who courageously focus on the source, which would directly benefit all consumers.
    Until we can force the government to accept accountability for its recurring misbehavior, your firm will have ever-increasing business, the medical profession will have lots of patients, and morgues will likewise benefit.
    John Munsell

  • jmunsell

    Phyllis, you ask “What happened to Prevention?” Please know that USDA/FSIS’ historical behavior is to require prevention at downstream entities, but certainly not at the SOURCE of contamination. As such, downstream entities such as further processing plants are responsible to (a) detect & (b) remove invisible pathogens. Oddly, neither the source slaughter plant nor FSIS was capable of accomplishing either (a) or (b) at the source. And, ostensibly lazy consumers are the other culprit in outbreaks, because they are not fully cooking pathogens to death. So, consumers are PRIMARILY responsible for prevention.
    I must admit that the current USDA/FSIS under secretary Dr. Elisabeth Hagen has made Prevention a high priority, as does her top aide Al Almanza, FSIS Administrator. They both have my respect and full endorsement. However, only time will tell if the system allows Dr. Hagen’s and Mr. Almanza’s laudable goal to become reality. I have no optimism on this issue.
    John Munsell

  • John,
    I tend to agree with your assertion that the federal government isn’t doing nearly enough to clean up the large food suppliers that continuously ship out contaminated food. As a local restaurant food safety inspector and avid advocate for improved food safety in our restaurants, I see the same practice by the FDA. Instead of going in and cleaning up the suppliers they put more pressure on restuarants to prevent outbreaks. I tell my clients that everyday they are receiving contaminated product into their stores and that if their food safety practices are not followed these products can lead to food borne illness.
    Ultimately, the restaurants pay the price for not controlling the impact of contaminated food shipped to them from irresponsible suppliers.
    Is it too much to ask the suppliers to ship product free of disease causing pathogens?
    Apparently it is.

  • For all I know this idea might already be in place or was thought of previously and shot down. How about a federal insurance plan for growers. Something similar to the banking industry’s FDIC. If a grower knows they have insurance to cover losses for reporting a contamination problem, and if they can save on the premiums by having few or no incidents perhaps that would help detect problems earlier and be incentive for growers to be more responsible.

  • John Munsell

    Bill, in your question #2 above, you asked “Is public health served when foodborne pathogens are trace to their source”. Your answer was “Yes”. Well, USDA/FSIS disagrees with your conclusion. Consider these historical facts: the meat industry’s largest plants implemented HACCP on January 26, 1998. On October 8, 2010, FSIS issued Notice 58-10 which authorized its inspectors FOR THE FIRST TIME to document the origin of meat being sampled for E.coli O157:H7. It took the agency ten years and 9 months of hand wringing before it finally liberated its personnel to cooperate with food safety officials and epidemiologists. Such opposition to public health imperatives would be akin to telling FDA and CalFERT investigators that they are prevented from documenting source information, and that they are NOT to determine the source farm which produced contaminated produce.
    Let me show you how this works. On 3 consecutive days in February 2002, agency-conducted ground beef sampling at my plant produced 3 consecutive positives proving the existence of E.coli O157:H7. The two agency employees at my plant hand-wrote a statement in which they identified Est #969 in Greeley, CO as the source of all 3 positives. During the agency’s subsequent mishandling of this issue, FSIS informed me that I would have to implement corrective actions to prevent this from recurring again. I asked the agency what actions I could take to prevent the Greeley plant from ever again shipping me contaminated meat. The agency’s blithe response was “Discontinue purchasing from that plant, and buy from other sources”. The agency thus continued its policy to require the destination facility to make changes, while insulating the SOURCE plant from accountability, allowing the source plant to continue operations as is, with no corrective actions. I unsuccessfully argued with the agency that not requiring changes at the SOURCE virtually guarantees additional outbreaks. In spite of this no-brainer, FSIS adroitly avoided requiring the large source plant to implement corrective actions to prevent recurrences. Well, what happened? It should surprise no one that four months later, the Greeley plant announced a 19.1 million lb recall. Even the venerable USDA cannot indefinitely hide the truth.
    Since this agency debacle at my plant, I’ve visited with many other plant owners who have been involved in recalls. Again, it should be no surprise that most if not all of these owners related that FSIS repeated the same nonsense at their plants, in that the agency merely suggested that the downstream further processing plant purchase from other source supplier slaughter plants……..while not requiring any changes at the large source slaughter plant. Bill, this is one reason why I continue to state that pathogens are NOT the primary enemy of public health! Instead, gov agencies which refuse to force the source to clean up their act are the deadliest enemy consumers face in America……..and USDA’s inaction is funded by our tax dollars.
    Unfortunately, as your article states, other entities such as FDA & CalFERT seem to be cloning FSIS’s unwillingness to force the source, virtually guaranteeing additional future outbreaks.
    Are these gov entities being paid under the table to covertly cover up damaging evidence, the release of which would not only enable consumers to make intelligent choices of what to buy, but would also dramatically improve food safety? I don’t know. But obviously, something is fishy here.
    When Carl Custer (FSIS microbiologist) suggested to his employer in 2003 that the agency should traceback to the SOURCE, the agency’s reply was “We won’t be involved in witch hunts”. Interpretation: FSIS refuses to be involved in tracebacks to the source, because such tracebacks would in most cases end up at the doorstep of one of the large slaughter plants, which enjoy political clout and the financial wherewithal to tie the agency’s hands in court. The “witch” in such cases are large, frequently multi-national plants. FSIS is paralyzed with fear of litigation emanating from the large plants. Because of this litigation fear, FSIS allows the large source slaughter plants to continue operations “As Is”. FSIS prefers to remain out of court and depends on you to sue downstream further processing plants as though these downstream entities INTRODUCED pathogens. You are right that sickened consumers deserve financial reimbursement for their sicknesses, loss of wages, etc. Unfortunately, the middle man is increasingly paying the price for insanitary conditions existing at their source suppliers, primarily because we have a government staffed with cowards.
    Our government’s refusal to trace back to the source, to require the source to clean up its act, and apparent unwillingness to disclose evidence, prevents consumers from making intelligent decisions of what to buy, and what brands to avoid. Here again, the largest manufacturers benefit from disclosure. A case in point is the opposition against Country Of Origin Labeling laws by the largest food processors, especially from multinational food entities which have the ability to source food from around the globe. Although consumers have the right to know where their food originated, multinationalist companies cry foul, accusing consumerists with “Protectionism”, “Irrational Nationalism”, and “Artificial Trade Barriers”, all outlawed by the World Trade Organization, to whom America now bows. A superlative example is the decision by the WTO that USA’s country of origina labeling law is illegal, in litigation brought by Mexico & Canada. These two countries demand that their meat be able to course through our 50 states without being labeled as being of Mexican or Canadian origin. It should be no surprise then that FDA and CalFERT overtly oppose the disclosure of origin information of contaminated produce, because frankly, such disclosure is politically incorrect, as defined by the WTO.
    Bill, I respectfully suggest that corporations run the show in the food chain, effectively thwarting any government or consumerist attempt to disclosure the source. Threats of WTO legal sanctions provide additional impetus to gov entities to do nothing, wasting our tax dollars. While such inaction provides comfort to gov authorities, severe consumer health discomfort (sometimes death) rears its ugly head as the logical consequence of the government’s implementation of laissez faire deregulation of our food supply. FSIS has publicly stated that its HACCP program is based in science, which requires FSIS to no longer police the industry, allowing the industry to police itself. This heinous feint places pressure on FDA & CalFERT to likewise embrace a “Hands Off” non-involvement role.
    Two conclusions: (1) We direly need bold leaders in the government, who audaciously pursue the source, disclose the source, and boldly tell the large companies “see you in court”. (2) These recalcitrant government do-nothing folks should be sued, even more aggressively than downstream food companies victimized by purchasing previously-contaminated food. I hate to say this, but FDA, FSIS and CalFERT should suffer dramatic reductions in funding until they willingly agree to proactively pursue investigations to the source, with full disclosure. We may need to jettison all the leaders of these feckless gov agencies, and replace them with folks like Lee Iacoca who courageously focus on the source, which would directly benefit all consumers.
    Until we can force the government to accept accountability for its recurring misbehavior, your firm will have ever-increasing business, the medical profession will have lots of patients, and morgues will likewise benefit.
    John Munsell

  • John Munsell

    Phyllis, you ask “What happened to Prevention?” Please know that USDA/FSIS’ historical behavior is to require prevention at downstream entities, but certainly not at the SOURCE of contamination. As such, downstream entities such as further processing plants are responsible to (a) detect & (b) remove invisible pathogens. Oddly, neither the source slaughter plant nor FSIS was capable of accomplishing either (a) or (b) at the source. And, ostensibly lazy consumers are the other culprit in outbreaks, because they are not fully cooking pathogens to death. So, consumers are PRIMARILY responsible for prevention.
    I must admit that the current USDA/FSIS under secretary Dr. Elisabeth Hagen has made Prevention a high priority, as does her top aide Al Almanza, FSIS Administrator. They both have my respect and full endorsement. However, only time will tell if the system allows Dr. Hagen’s and Mr. Almanza’s laudable goal to become reality. I have no optimism on this issue.
    John Munsell

  • John,
    I tend to agree with your assertion that the federal government isn’t doing nearly enough to clean up the large food suppliers that continuously ship out contaminated food. As a local restaurant food safety inspector and avid advocate for improved food safety in our restaurants, I see the same practice by the FDA. Instead of going in and cleaning up the suppliers they put more pressure on restuarants to prevent outbreaks. I tell my clients that everyday they are receiving contaminated product into their stores and that if their food safety practices are not followed these products can lead to food borne illness.
    Ultimately, the restaurants pay the price for not controlling the impact of contaminated food shipped to them from irresponsible suppliers.
    Is it too much to ask the suppliers to ship product free of disease causing pathogens?
    Apparently it is.