Delays in Pepper Recalls Threaten Public Health

From July 2009 through February 2010, at least 252 people were infected by Salmonella as a result of consuming Daniele, Inc. salami products that were manufactured using contaminated pepper.  The salami actually contained two kinds of pepper, red and black, both of which may have been contaminated.  Daniele purchased the contaminated pepper from two different companies:  Mincing Overseas Spice Company and Wholesome Spice Co, who have since initiated recalls of their contaminated products.  Ever since, multiple food companies from across the country have inititated their own recalls because they contained pepper from Mincing and Wholesome spice companies.  And just this week, two more companies, CH Guenther and Sons and Spice Barn, Inc., have recalled their pepper products as a result of Mincing's outbreak/recall.

A recall can be a very effective tool to prevent a dangerous product from injuring or killing somebody.  But the effectiveness of the recall process depends on the speedy and free flow of information, and particularly in the context of a raw food item subject to further processing, also the ability to effectively track where the dangerous products are ("traceability"). 

If companies are just now recalling pepper products sold by Mincing and/or Wholesome spice companies, there is a big problem.  Here are a few thoughts on what the problem might be:

1.  Maybe Mincing and Wholesome spice companies thought their obligations ended after recalling their contaminated product.  Not so.  Whether it appears in a statute or not, recalling companies have an obligation not only to announce the recall but also to act aggressively in (a) identifying what retailers or other companies may have received the contaminated product (b) identifying what consumers may have purchased the contaminated product and (c) using all means necessary to make the important details of the recall (e.g. what products are included) known to retailers and consumers alike.

2.  Another possibility that we frequently see in recall situations is that the recalling company has simply taken too narrow of an approach to the scope of its recall.  In other words, its initial recall efforts did not include all contaminated products.  There is no solution to this problem that perfectly balances a business's economic interests with public safety.  Clearly, a company cannot recall all of its products because to do so may mean corporate death.  But in the name of public health, it absolutely has to take a broad approach to to assessing what products are potentially implicated by the problem.  Thus, it is critical that food companies are able to accurately track which of its products are potentially implicated in a contamination problem.

What has happened to prompt these pepper recalls now, a month and a half after pepper was first suspected to be the source of infection in the major national outbreak linked to Daniele salami, is not yet publicly known.  But the fact that these recalls are happening so late in the game is absolutely unacceptable.  True, a late recall is better than no recall at all, but if a company is discharging the obligations described above and is serious about its efforts to protect the health of its customers, then information leading to such recalls has to be disseminated much faster. 

There was certainly a failure, probably many, somewhere along the line in this large outbreak and recall.  The questions that now remain unanswered are (1) how many more companies still have contaminated pepper products from Daniele, Overseas, and Wholesome spice companies in the marketplace, and (2) how many more people will fall ill as a result of the brutally slow flow of information critical to the protection of public health?

Second Salami recall of 2010 issued by Siena Foods LTD

The U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) issued a public health alert tonight due to illnesses possibly associated with ready-to-eat (RTE) deli meat products that may be contaminated with Listeria monocytogenes.

The products subject to the recall were produced by Siena Foods LTD, a Toronto, Ontario, establishment.  Recalled products include, but are not limited to, "Cacciatore Salami, Mild," "Coppa," "Prosciuttini," "Prosciuttini Hot," and "Prosciutto Cotto." The individually wrapped products have variable weights and a "Best Before" date through June 22, 2010, as well as the establishment number "Est. 212" inside the CFIA mark of inspection. However, the original brand and/or best before dates may not have been transferred at the deli counters to consumer packages. Persons who may have purchased any of these products and do not know original brand and code are advised to check with their retailer or supplier to determine if they have the affected product.

FSIS was informed by the Canadian Food Inspection Agency (CFIA) that products subject to recall in Canada may have been exported to the United States. This public health alert was initiated after positive test results and an investigation by CFIA in response to a listeriosis illness outbreak. At this time, no confirmed linkage has been made between the products subject to recall and the reported illnesses. 

Black pepper recall grows

The FDA announced yesterday that yet another company is recalling black pepper products as a result of Salmonella contamination.  This recall is related to the Mincing Overseas Spice Company recall that occurred on the heels of a major salmonella outbreak linked to Salami products manufactured and sold by Daniele Inc. 

The FDA announcement reads as follows:  As a result of a recall of Black Pepper by Mincing Overseas Spice Company and distributed by Dutch Valley Food Distributors due to the possibility of contamination with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems, a product recall is being issued. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting, and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e. infected aneurysms), endocarditis and arthritis.

Dutch Valley Food Distributors, Inc. has issued a voluntary recall for the following products with a Bulk Foods Inc. label:

5 Pound boxes of Seasoning Salt, item 808530, with a Mfg. date of 1/4/10 and 2/2/2010
5 Pound boxes of Perfect Pepper Seasoning, item 808399, with a Mfg. date of 1/4/2010
5 Pound boxes of Perfect Pepper Dip Mix, item 278115, with a Mfg. date of 12/7/2009
5 Pound boxes of Vegetable Dip Mix, item 278112, with a Mfg. date of 1/4/2010 and 2/2/2010
5 Pound boxes of Southwest Dip Mix, item 278109, with a Mfg. date of 2/2/2010

50 Pound boxes of Medium Black Pepper, item 808464 with a lot number of 3309 (B, F, G, K, P and T) and 3258 (B, D, G, L, P, Q, R, T and X)
20 Pound boxes of Coarse Black Pepper, item 808465 with a lot number of 3309 (B, F, G, K, P and T) and 3258 (B, D, G, L, P, Q, R, T and X)
25 Pound boxes of Fine Black Pepper, item 808466 with a lot number of 3309 (B, F, G, K, P and T) and 3258 (B, D, G, L, P, Q, R, T and X)
50 Pound boxes of Fine Black Pepper, item 808467 with a lot number of 3309 (B, F, G, K, P and T) and 3258 (B, D, G, L, P, Q, R, T and X)
25 Pound boxes of Whole Black Peppercorns, item 808468 with a lot number of 3309 (B, F, G, K, P and T) and 3358 (B, D, G, L, P, Q, R, T and X)
20 Pound boxes of Medium Black Pepper, item 808469 with a lot number of 3309 (B, F, G, K, P and T) and 3358 (B, D, G, L, P, Q, R, T and X)
5 Pound pails of Whole Black Peppercorns, item 808470 with a lot number of 3309 (B, F, G, K, P and T) and 3358 (B, D, G, L, P, Q, R, T and X)

All items packaged and sold within the parameters mentioned are subject to this recall, including items sold on our website, www.dutchvalleyfoods.com1. The items were distributed nationwide. Retailers are advised to remove all these products from store shelves based on lot number or manufacture dates. Consumers who have purchased these products are asked to destroy them. Consumers with questions regarding the products listed may call Dutch Valley Foods at 1-800-733-4191 and speak with customer service. For more information on FDA’s ongoing investigation, visit the FDA’s website at www.fda.gov2.

 

Mincing Overseas black pepper added to salami/pepper recall (correction to earlier blog post)

We have been following the large outbreak and recall linked to Daniele Inc. salami products since the middle of January.  The outbreak began in July 2009, but was not discovered until January 2010.  Two strains of Salmonella--Montevideo and Senftenberg--are known to have been involved.  The recall began on January 23, 2010, with Daniele's recall of 1,263,754 pounds of salami products, eventually expanded to include almost 1.3 million pounds of salami products.  Now, nearly a month and a half after the outbreak and recall was announced, and after a total of 245 confirmed illnesses have been reported nationally, the FDA is announcing that Mincing Overseas Spice Company of Dayton, NJ, has recalled its black pepper product.  After a little further research, it appears that Mincing Overseas actually began recalling its products back on February 25, 2010.

Earlier today, I indicated that the Mincing recall did not occur until today, but it appears that that statement was incorrect.  See Mincing's February 26, 2010 statement.  Only the FDA's announcement of the recall occurred today.  But if that's the case, isn't it a little concerning that the FDA, one of the two federal agencies whose job is, in part at least, protecting the public's health didn't announce Mincing's recall until today, two weeks after the the company initially announced the recall?  Maybe I'm missing the FDA's earlier recall notice . . .

Update on Daniele salami/pepper Salmonella outbreak

Yesterday, the CDC updated the case count in the Salmonella outbreak linked to recalled salami from Daniele Inc., red pepper from Wholesome Spice, and likely black pepper as well.  A total of 245 people are now counted by the CDC as cases in this outbreak, coming from 44 states and the District of Columbia.  But this is not the whole story.  The 245 figure does not include any Salmonella senftenberg illnesses, another strain of salmonella that we have long known has been causing illnesses in this outbreak. 

As for the Salmonella montevideo illnesses in this outbreak, as stated, there are 245 of them.  The distribution nationally is as follows:  AK (2), AL (2), AZ (7), CA (30), CO (5), CT (5), DC (1), DE (3), FL (3), GA (3), IA (1), ID (4), IL (19), IN (4), KS (5), LA (1), MA (14), MD (1), ME (1), MI (4), MN (6), MO (2), MS (1), NC (11), ND (1), NE (3), NH (2), NJ (9), NM (2), NY (18), OH (9), OK (1), OR (9), PA (7), RI (2), SC (1), SD (3), TN (5), TX (7), UT (9), VA (1), WA (17), WI (1), WV (1), and WY (2).

But what about Senftenberg?  The CDC says:

Salmonella Senftenberg, a different serotype of Salmonella, has been found in food samples from retail and a patient household during this outbreak investigation. PulseNet identified 6 persons who had illness caused by Salmonella Senftenberg with matching PFGE patterns between July 1, 2009 and today. Public health officials have interviewed 5 of the 6 ill persons with this strain of Salmonella Senftenberg and determined that two purchased a recalled salami product during the week before their illness began. These six cases are not included in the overall case count reported above.

One of the positive salami samples was from Lee Hanks, our client from Missouri whose salami twas truly a ticking time bomb, testing positive for both strains of Salmonella .  Lee tested positive for Salmonella Montevideo, so he is most likely included in the CDC's case count, but why are these 6 Senftenberg illnesses not included in the CDC's official case count?  Two of the 6 had purchased recalled Daniele salami in the week before their illnesses, but what about the other four?  Does the CDC suspect that the contaminated pepper is in other products, and that these Senftenberg illnesses may in fact be associated with the same contaminated pepper, just from another food product? 

Notably, the two potential suppliers of black pepper to Daniele (at least the two that are publicly known) have not recalled black pepper, despite an announcement by the Rhode Island Department of Health that a sample of the black pepper had tested positive for the outbreak strain of Salmonella Montevideo.  But, two days ago, Heartland Foods, Inc. an Indiana company, did recall black pepper.  Still many unanswered questions in this outbreak.

Spices: emerging threat or clear and present danger?

Over the last several years, there have been multiple outbreaks linked to, and recalls of, various kinds of spices. From white pepper, to red pepper, to black pepper and beyond, spices are a potentially ideal vehicle for the transmission of foodborne disease. More and more people are becoming ill from contaminated spices, and more and more recalls are occurring. So is this problem merely an emerging threat? Or is it a problem that food producers must confront here and now, finding ways to better ensure the safety of the consumers they profit from.

Spice outbreaks in recent history:

1. Veggie Booty

In May 2007, the Centers for Disease Control and Prevention (CDC) began a multi-state investigation in response to an increase in laboratory reports, first posted on PulseNet on April 2, 2007, of Salmonella Wandsworth. Salmonella Wandsworth is a very rare serotype that was never before implicated in a U.S. outbreak. As of September 6, 2007, there were 69 reported cases of Salmonella Wandsworth in 23 states and 14 cases of Salmonella Typhimurium in six states who became ill after consuming Veggie Booty, a puffed vegetable snack food with a raw, dried vegetable coating. A total of 61 bags of Veggie Booty were ultimately tested in twelve states. Salmonella was isolated from thirteen of them. Eleven of the thirteen bags were positive for the outbreak strain of Salmonella Wandsworth, and one bag was positive for Salmonella Typhimurium and Enterobacter sakazakii. One bag also tested positive for Salmonella Kentucky, and Salmonella Haifa and Saintpaul were isolated from other bags.

2. Union International

The Union International Food outbreak sickened more than 79 people in Western states between December 2008 and April 2009; the majority of the illnesses were in California. Public health officials traced the outbreak to white pepper manufactured by Union International and sold under the brand names Uncle Chen and Lian How. Ultimately the company recalled more than 50 products, including spices, oils, and sauces, due to potential contamination with Salmonella.

3. Wholesome Spice Company and Overseas Spice

This outbreak and recall is, of course, still going on.  According to the CDC just days ago, 238 individuals infected with the outbreak strain of Salmonella Montevideo, which displays either of two closely related pulsed-field gel electrophoresis (PFGE) patterns, have been reported from 44 states and District of Columbia since July 1, 2009.  Epidemiological investigation showed that these 238 sick people all ate Daniele Inc salami products contaminated by salmonella.  Daniele used salmonella-contaminated pepper in the production of the various kinds of recalled salami. 

4. Today’s recall of Johnny’s brand French dip au jus powder?

Will the Johnny’s recall, announced today out of Tacoma, Washington, be another recall or outbreak to add to this list? The ingredient list for the recalled prodcut states that it contains: 'MSG, Wheat, Soy & Milk; Hydrolyzed vegetable protein (corn, soy, wheat), yeast extract, salt, rice flour, monosodium glutamate, partially hydrogenated vegetable oil (soy & cottonseed), caramel color, whey solids, non-fat milk solids, mono & diglycerides."  Only time will tell, hopefully, what happened at Johnny's to prompt today's recall.  Spices?  Certainly possible.

The historical trend:

These kinds of events naturally prompt the question why are we suddenly seeing outbreaks and recalls linked to pepper and other spices. Is this truly a new phenomenon; a new species of failure by food importers and producers? 
 

The combination of Google and about 5 spare minutes will show you that spice problems are, by no means, a new phenomenon. As stated in a 2006 Journal of Food Protection article (“Journal article”): "We reviewed spice recalls that took place in the United States from fiscal years 1970 to 2003. During the study period, the FDA monitored 21 recalls involving 12 spice types contaminated with bacterial pathogens."  See Journal of Food Protection, Vol. 69, No. 1, 2006, Pages 233–237(Recalls of Spices Due to Bacterial Contamination Monitored by the U.S. Food and Drug Administration: The Predominance of Salmonellae). See article at: http://www.cdc.gov/enterics/publications/381_vij.pdf.

Indeed, as the name of the Journal article suggests, the problem of spice contamination has long been known. And not only that, it has long been known to be predominantly one of Salmonella contamination specifically.

Defining the problem:

Lest we delude ourselves into believing that the risk is not that great, it is clear that spice outbreaks are on the rise. The Journal article further states that “Although five of these recalls transpired during the preceding 30 years (one each in 1971, 1983, 1989, 1995, and 1996), the remaining 16 (76%) occurred during fiscal years 2001 to 2004.” And the other outbreaks described above (i.e. Veggie Booty, Union International, Wholesome/Overseas, and possibly Johnny’s) are too recent to have been included in the Journal article’s study.

But to add even further concern, it is evident that counting recalls and outbreaks may only partially define the problem. The Journal article further notes that, of the 105,440 spice brands imported at the time into the US, 258 were coded as "refusals" and were thus prevented access to US markets:

178 (69%) were refused because the manufacturer had a history of shipping Salmonella-contaminated spices. In 131 (74%) of these 178 refusals, the importer chose not to challenge the refusal; in 44 (25%) instances, Salmonella was shown to be present by laboratory analysis. In the remaining three (1%) instances, the spices were refused because of the presence of mold or filth.

Thus, upon inspection, there were an additional 258 refusals of spice products during the one year period analyzed, thereby preventing those contaminated spices from being included in the Journal article’s analysis. Admittedly, some were refused entry only because of past problems associated with the exporter, and some due to contamination by mold or other filth, but 44 were refused entry because they were, in fact, contaminated.

Where do all these contaminated spices come from? Again, the Journal article:

The country of origin of the spice was known for 15 recalls: 12 involved imported spices (India [three recalls], Spain [three recalls], Turkey [two recalls], and one recall each from Egypt, Jamaica, Mexico, and Taiwan), and the remaining three involved domestically produced spices (two recalls due to Salmonella and one recall due to L. monocytogenes).

Further:

Overall, there were 6,112 unique spice manufacturers in the 129 nations from which the United States imported spices; the three countries with the leading numbers of spice manufacturers were India (629 manufacturers), China (547), and Mexico (441). During fiscal year 2003, there were 9,911 unique spice consignees in the United States who purchased imported spices. Approximately 85% of the spices imported in fiscal year 2003 were produced in China, and the next four leading spice exporters to the United States—Honduras, Mexico, Lebanon, and Peru—contributed an additional 13%.

Further defining the problem:

As we know from past experience with food products, certain items are more susceptible to contamination, or to causing higher rates of infection and illness, due to their very nature. For instance, ground beef is a risky food because of the oftentimes preventable contamination that is so rampant in the production process. And lettuce and other leafy greens are susceptible to contamination because they are grown in an environment particularly capable of causing the contamination. 

Spices have numerous “performance characteristics” that make them a ready vehicle for contamination and illness. First, they are generally a dried product that have a long shelf-life . . . even for those of us who do not have spices still on our shelves for the 1990s. Second, they are ubiquitous and widely-sold; everybody has them, and everybody eats them, from the very healthy to the young and old, and all people in between. Third, the Salmonella bacteria, which is far and away the most prevalent contaminant of spices, is a hearty bug capable of surviving for long periods in a dry environment (e.g. a container of spices). As the Journal article notes, in a 1993 spice outbreak in Germany, testing 8 months after the contaminated product was identified produced positive results for viable Salmonella bacteria.

And the threats from a public health and surveillance standpoint? Long shelf-life frustrates the efforts of investigating health authorities to detect outbreaks and stop them.  Also, again, everybody eats these spices, which works to the detriment of public health in investigating spice outbreaks because investigators are not necessarily able to hone in on the suspect product as easily. Even though everybody buys them and uses them, people may use many different brands on their shelves and would not be able to retrospectively identify which particular brand they used days, weeks, or months ago.  And finally, spices are often a post-cooking flavoring ingredient, and thus there is often no kill step.

So what are we to do?

Certainly, the solution does not lie in not using the product. Very few, even among those who truly know the scope of the problem, will stop using spices altogether. And nor does the solution lie in preventing US food companies from using imported spices. These solutions are both totally unrealistic, forcing the bottom line conclusion that the food companies themselves must act as a buffer against the purchase, manufacture, and distribution of contaminated spices.

With respect to spices, the buck stops with the industry. It is time for the process of irradiation to gain a stronger foothold in the United States with respect to all products, and most definitely with respect to those food products that carry the greatest risk.

But irradiation is not the only answer. The Journal article describes others as well:

A number of methods exist to reduce or eliminate pathogens from spices (e.g., the use ethylene oxide, heat treatment, or irradiation [UV, infrared, or gamma]). Ethylene oxide is highly diffusive; is simple to use; does not significantly alter either the aromatic or flavor components of spices (unlike heat treatment, which can destroy the aromatic and flavor components of spices as well as their color (12)); and is effective in destroying microorganisms (18). However, the effect of ethylene oxide on spores is not as great as it is for vegetative cells (12). The FDA has established a maximum tolerance of 50 ppm for residues of ethylene oxide in ground spices (2). On the other hand, at least one study has suggested that irradiation represents the most effective and safe method of treatment of spices, and it is a process that yields no toxic by-products (17). For the microbial disinfection of spices, the FDA has established that, when irradiation is used, the maximum dose should not exceed 30 kilogray (3 Mrad) (3).

And yet another solution is good old fashioned hard work by food companies. Do your job better by instituting and following rigorous standards in the import, production, distribution, and sale of your products. This involves knowing your suppliers, and their track-record with respect to food safety; don’t simply look at cost as the sole conclusive factor in deciding who to buy spice products from. Also, take all necessary precautions to avoid contaminating your production environment. This was certainly a factor in the Union International outbreak, and possibly one in the Daniele salami outbreak linked to black and red pepper. And finally, as is the case in any outbreak of foodborne illness, act quickly and proactively in informing the public and investigating health authorities about the probability and scope of a contamination problem with your products. Media exposure, and the resulting business loss, that occurs in the wake of outbreaks and recalls is only worse when more people get sick; and hiding the ball is certainly a good way to make more people sick.
 

Salmonella contaminated pepper and salami: is the outbreak over?

There has been no further word on the massive Salmonella outbreak that sparked a major recall by Daniele Inc. of salami products distributed nationally.  The latest CDC update on the outbreak was on February 18, at which point the CDC had identified 233 illnesses in 44 states linked to the outbreak.  But as of the date of the CDC's last update, there remained many unanswered questions in the outbreak investigation.

To recap, Daniele Inc has recalled a total of almost 1.4 million pounds of salami products, some produced as recently as mid February.  See list of recalled products.  It is widely thought that both red and black pepper used during production of the recalled salami products was the original source of contamination.  Daniele Inc's pepper suppliers are two companies called Overseas Mincing Spice Company and Wholesome Spice Company.  Daniele has terminated its relationship with Wholesome Spice Company and now reports that it is using irradiated pepper exclusively in its products. 

But it has been nearly a week since we have received any word on the status of the outbreak, despite epidemiological evidence that contaminated products may in fact still be in consumer households.  So, are people still getting sick?  Are we dealing with an ongoing threat to public health?  Has all potentially contaminated product been recalled?  And what is the latest on the status of the investigation into the pepper, both red and black, that has been identified as the original source of contamination?  Notably, neither pepper company, Overseas Spices or Wholesome Spice Company, has recalled any of its products.  What is the significance of this?  There are only three possibilities:  (1) the true source of contaminaton was at Daniele alone, (2) the pepper companies did not sell the contaminated pepper to any other companies, and they are confident that the Daniele recall is broad enough to include all potentially contaminated pepper, or (3) the companies simply have not acted to protect public health.  We would like to think, in this day and age and in this country, that the third possibility is, in fact, not possible, but events over the past several years are cause for concern.  Recall that we are only one year removed from the now infamous PCA salmonella outbreak, in which Stewart Parnell knowingly sent salmonella-contaminated product on to other companies for inclusion in peanut-based products.

 

As Daniele Inc recall expands, questions do too

Yesterday evening, the USDA's Food Safety and Inspection Service (FSIS) announced that Daniele Inc is expanding its January 23 2010 recall of salami products to include another 115,000 pounds of potentially contaminated salami.  See list of recalled products.  The expansion is yet another twist in an outbreak that has continued to evolve, and with sometimes only limited information passed to the public by investigating health officials and the companies involved. 

But the recent expansion is more significant for the many questions that it creates.  It is based upon the presence of salmonella in salami packages that did not contain any black pepper, which has long been thought to have been the source of contamination in the outbreak.  Now, health authorities believe that crushed red pepper included in some of the Daniele Inc product may have been contaminated as well.

Here is a quick list of questions that need to be answered:

1.  Who is the supplier of red pepper? 

Why it matters:  if tests have indicated the presence of salmonella on the crushed red pepper that Daniele Inc used, the same contaminated pepper may have been distributed to other food producers or retailers, so more foods may be, or might become, contaminated.  Pepper has a long shelf life, so if this product is, indeed, elsewhere in the consumer chain of distribution, it represents an ongoing threat to human health.

2.  How many strains of Salmonella are implicated in this outbreak, and what are they?

The FSIS press release about the recall expansion tells us that crushed red pepper may now be contaminated, but says nothing about the strain of salmonella that was isolated.  We know Montevideo, and we know Senftenberg, It would seem unlikely, unless the supplier of the black and red pepper was the same, that both would be contaminated with the same strains of Salmonella.  Maybe the red pepper was contaminated with one, and the black with the other; or maybe the black with both known strains, and the red with a totally new strain.  Whatever the case, the public should have the benefit of this knowledge. 

3.  Have all potentially contaminated products been recalled?

Surely, the companies involved would say yes, but yesterday's announcement is, after all, effectively the third announced recall by Daniele, each one including more and different products.  So, has Daniele Inc taken a conservative approach to recall?  Or has it acted as broadly in scope as the ongoing risk to public health would seem to dictate. 

But at least Daniele has acted.  One thing causing great concern, here at least, is that there has been no recall of pepper, either the black or the red, despite tests that have confirmed the presence of salmonella in pepper from two, and maybe even three different companies.  Maybe Daniele was Overseas Spice and Wholesome Spice's only customer, and those companies have accurately determined that there is no ongoing risk because Daniele's recalls encompass all the potentially contaminated product.  We can only speculate at this point, but that doesn't sound like a sustainable business model. 

4.  Is the model currently in place for telling the public crucial information about outbreaks and recalls really the most efficient method we can think of?

The flow of information to the public about this major outbreak has been slow.  Recall that the CDC announced this outbreak in January by stating that the implicated product was "a widely distributed contaminated food product."  At the time of the CDC's announcement, it was certainly known by US Government that Daniele Inc's salami was the "widely distributed contaminated food product."  But instead of the CDC just saying that, it fell to Bill Marler, a private citizen way out in the northwest corner of the country, to announce what the product really was.

On her blog, Obamafoodorama.com, Eddie Gehman Kohan asked "How is it possible that a blogger notifies the public of a new Class I (you could die) recall of 1,240,000 pounds of meat before USDA does?":  She continued, "It's a grim situation when a private citizen is more on the ball than the federal agency that's supposed to be managing national food safety concerns (CDC's own e mail heads-up about the outbreak included no information, except that a product sold nationally was contaminated with Salmonella Montevideo)."

So back to the original question, is a system that is so reliant on the private sector--instead of first responders like the government, CDC, FDA, FSIS--to pass information about food outbreaks really an efficient model?  There are 230 recognized illnesses in this outbreak, many of which fell ill long before the pieces to the puzzle had fallen into place, but certainly some of whom fell ill after government and certain industry members knew the most essential details.  Clearly, this is not efficient from a public health standpoint, and some would certainly argue that it's not very efficient from a business standpoint either.  After all, the losses generated by the publicity surrounding these outbreaks in the form of reduced sales and lawsuits certainly compound the longer the outbreak remains in the public spotlight.  And one sure way of accomplishing that is to deliver information piecemeal and untimely.

 Many questions yet to be answered as this outbreak continues to unfold. 

Another lawsuit filed in Salmonella outbreak linked to salami and black pepper

Today Marler Clark filed a lawsuit on behalf of Raymond Cirimele, another victim of the Salmonella outbreak linked to salami manufactured by Daniele, Inc., and black pepper sold by Wholesome Spice Company and Overseas Spice Company.  Another suit was filed on behalf of a Missouri man named Lee Hanks last week.

Raymond Cirimele regularly purchased the now-recalled salami product at a Costco in Cook County. He fell ill in November 2009 with symptoms of Salmonella infection, and visited his primary care physician. He was ill for almost a month, and visited his doctor several times about his illness. When a test revealed that he had been infected by the outbreak strain of Salmonella montevideo, Mr. Cirimele was placed on antibiotics. He is still recovering from his illness.

As of 9:00 pm EST on February 10, 2010, a total of 225 individuals infected with the outbreak strain of Salmonella Montevideo, which displays either of two closely related PFGE patterns, have been reported from 44 states and District of Columbia since July 1, 2009. The number of ill persons identified in each state with this strain is as follows: AK (1), AL (2), AZ (6), CA (30), CO (4), CT (5), DC (1), DE (2), FL (3), GA (3), IA (1), ID (2), IL (15), IN (3), KS (3), LA (1), MA (13), MD (1), ME (1), MI (4), MN (5), MO (2), MS (1), NC (10), ND (1), NE (1), NH (2), NJ (8), NM (2), NY (18), OH (9), OK (1), OR (9), PA (6), RI (2), SC (1), SD (3), TN (5), TX (7), UT (9), VA (1), WA (17), WI (1), WV (1), and WY (2). Because the main Salmonella Montevideo outbreak PFGE pattern is commonly occurring in the United States, public health investigators may determine that some of the illnesses are not part of this outbreak.

The Silence of the Pepper Continues

It is Sunday, February 7, 2010; fifteen full days since Daniele Inc announced a recall of its salami products; and almost as long since the companies and investigating health authorities involved have either suspected or known that the ultimate source of illness in this large, and possibly growing outbreak, is black pepper.  But we, the food consuming public, continue to know nothing about the whereabouts of the contaminated pepper.  Why the silence?

To recap:  The CDC now counts 213 confirmed cases of Salmonella montevideo illnesses stretching from July 2009 to the present.  The cases are scattered across the country; 42 states in total; and California, Washington, Illinois, and Massachussets are the hardest hit states, with 30, 15, 13, and 12 cases respectively. Daniele Inc has recalled 1.28 million pounds of potentially contaminated product.  The Rhode Island health department announced on February 3 that it had detected the outbreak strain of Salmonella montevideo in pepper samples from two of Daniele Inc's pepper suppliers, Overseas Spice Company and Wholesome Spice.  Neither company, nor any government agency involved in the investigation (including FSIS, CDC, and USDA) has announced whether other food companies have received any of the contaminated pepper, or even whether the contaminated pepper is sitting on store shelves.  Nor has there been a recall of the contaminated pepper. 

From a public health standpoint, the proper flow of information would dictate that the public be made aware of where the contaminated pepper is; alternatively, if the companies involved and the governmental agencies investigating the outbreak have information to suggest that there really is no ongoing risk to the public, we should know that too. 

Most of the ire about the slow flow of information in this outbreak exists because of the potential that the outbreak is broader than simply contaminated salami.  We know that it wasn't the meat that was contaminated; it was contaminated pepper that ultimately caused the meat to become contaminated.  The pepper came from two companies who obviously had the same supplier of pepper.  Those pepper companies, Wholesome and Overseas, likely have more than one customer, thus creating the risk that more than Daniele is in possession of, or has used, the contaminated pepper.  And critically, there has been the suggestion, at least, that some people who are counted as outbreak cases (i.e. confirmed with the outbreak strain of Salmonella montevideo) did not even have any reported consumption of Daniele Inc salami in the days prior to their illnesses.  If true, this means that there must be more products that are making people sick, and may still be on store shelves. 

Some of the ire, though, exists because this is not an isolated instance of the slow flow of information in food outbreaks.  Recall that the E. coli O157:H7 outbreak linked to beef products from National Steak and Poultry was announced on Christmas Eve--probably the worst time possible to announce an outbreak and recall because most consumers simply aren't paying attention to recalls at that point in time.  Another example is the West Missouri Beef recall of 14,000 pounds of potentially contaminated boneless beef products.  Apparently, the meat was distributed to Chicago-area wholesalers, yet neither FSIS nor the company itself has disclosed the retail locations that received the potentially contaminated products. 

So the silence of the peppers continues.  If there is an ongoing risk to the public, we should have the benefit of knowing that so that we can make an informed choice about what products to buy.  If there is no ongoing risk to the public, we should have the benefit of knowing that information too. 

15 Washington Residents Sickened in Salami/Pepper Salmonella Outbreak

The CDC's February 2 update on the Salmonella outbreak linked to salami and black pepper indicates that Washington, with 15 victims, is among the hardest hit states in the outbreak.  Only California and New York, with 30 and 16 victims respectively, have more sick residents.  Here is a distribution map of illnesses linked to the outbreak:

The latest update on the outbreak:

Rhode Island Department of Health has confirmed that the black pepper used to manufacture Daniele Inc's salami products has tested postiive for Salmonella Montevideo, thus confirming that the pepper was the ultimate source of contamination in the outbreak.  Rhode Island has also indicated that black pepper from two of Daniele Inc's spice suppliers (Wholesome Spices and Oversees Spice Company) has tested positive for the outbreak strain of salmonella.  This means that Wholesome and Oversees must have purchased their black pepper from the same supplier. 

This outbreak may not be over.  Unfortunately, the FDA and CDC have been largely silent on the nature of the ongoing risk to the public.  And Wholesome and Oversees have not yet heeded calls to tell the public whether they sold contaminated product to other companies, so we do not yet know whether other food producers have been using the contaminated product.  In fact, it seems very likely that they did.  There is some indication that certain outbreak victims had no exposure to salami whatsoever in the timeframe of their illnesses, yet they match the outbreak strain of Salmonella.  The implication is that there is, in fact, another food that is, or was, making people sick.

 

A good point about the Salmonella salami/pepper outbreak

In response to my AM's blog post about the true scope of the Salmonella salami/pepper outbreak, a reader states as follows:

Can't you read between the lines Drew. The contaminated pepper was sent to
food plants all over the country, to supermarkets, restaurants etc. Its
everywhere. The only safe products now may be from Daniele Inc..The RI dept
of health and FDA have both confirmed positive salmonella in unopened
pepper. The truth is too big for you to get your mind around. This is a
big huge mess and now could be a bigger cover up. Someone should inform
people of the truth...

Good point.  Where else is the contaminated pepper?  What do our national public health agencies know about the pepper product (other than that it's from Vietnam), and when do we get the benefit of having them disclose what they know?  Is there any ongoing risk to consumer health?  Is the pepper in our homes?

The True Scope of the Salami/Pepper Salmonella Outbreak

The CDC reported yesterday that there are 203 confirmed "cases" (i.e. victims who's stool sample has tested positive for the outbreak strain of bacteria) in the recent Salmonella outbreak linked to recalled salami (Daniele, Inc.) and the ingredient pepper (Wholesome Spice).  The outbreak is truly nationwide, having sickened people in at least 42 states and the District of Columbia.  But as in any outbreak situation, particularly one involving a relatively common product distributed over a wide geographic region over a seven month time frame, there are many more people ill across the country than the CDC's official count would suggest.

A leading study on the subject suggests that the number of actual victims in a given outbreak, as opposed to merely those with positive stool samples, is as much as 38 times the number of stool sample confirmed individuals. See Paul Mead et al.  http://www.cdc.gov/ncidod/EID/vol5no5/mead.htm.

There are several reasons why. First, it is highly unlikely that, considering the widespread distribution and availability of the potentially contaminated products, only the salami and pepper consumed by official "cases" was contaminated with Salmonella. More likely is that many more of the individual packages of salami were contaminated.  After all, Daniele Inc. has now recalled 1,257,000 pounds of Salami.  The 203 confirmed victims in this outbreak have certainly not purchased, much less consumed, that much salami.  

Second, as noted by Mead et al., underreporting of foodborne disease is common. See Mead Article at 607. “Surveillance of foodborne illness is complicated by several factors. The first is underreporting. Although foodborne illnesses can be severe or even fatal, milder cases are often not detected through routine surveillance.” It is frequently the case that only the more severe illnesses come to the attention of health department officials. The less severe illnesses in any given outbreak often require less medical treatment, and the possibility that the causative agent—e.g. Salmonella bacteria—will be identified decreases as well.

 Many cases of foodborne illness are not reported because the ill person does not seek medical care, the health-care provider does not obtain a specimen for diagnosis, the laboratory does not perform the necessary diagnostic test, or the illness or laboratory findings are not communicated to public health officials.

 See Mead Article at 609.

 Additionally, the likelihood that secondary transmission of Salmonella-bacteria occurred must be considered. As stated in the Mead Article, “many pathogens transmitted through food are also spread through water or from person to person, thus obscuring the role of foodborne transmission.” See Mead Article at 607. In other words, it is common in outbreak situations for people who became infected by contaminated food to thereafter sicken co-workers or family members by unwitting transmission of a small amount of bacteria.

Finally, in this particular outbreak, it must also be considered that the CDC's official "case" count is only for Salmonella Montevideo, which is the only strain that the CDC has officially linked to the recalled, contaminated product.  But the CDC has itself stated that testing by at least one State Health Department has detected the presence of other strains of Salmonella in or on the recalled product. It is difficult to accurately estimate the number of people who have suffered illness, confirmed by stool test or not, due to infection by a strain of Salmonella that has not even been made public. 

These circumstances constellate to make it highly likely that the salami outbreak is much larger than just 203 sick people. As Mead states:

 To calculate the total number of illnesses caused by each pathogen, it is necessary to account for underreporting, i.e., the difference between the number of reported cases and the number of cases that actually occur in the community. For Salmonella, a pathogen that typically causes nonbloody diarrhea, the degree of underreporting has been estimated at ~38 fold . . . [W]e used a factor of 38 for pathogens that cause primarily nonbloody diarrhea (e.g. Salmonella, Campylobacter).

See Mead Article at 607.  

203 multiplied by 38 is a big number  =  7,714.

Salmonella, spices, and what Daniele and Wholesome should have known

A reader's comments about the journal post this morning titled "Unanswered questions remain in the Salmonella salami/pepper outbreak:"

As a former owner of a spice company that did extensive work with food processors, I agree that the public has a right to know the information pertaining to this outbreak. However, using and/or selling untreated pepper is much akin to playing Russian Rullette with 5 bullets in the chamber. The price you pay to have pepper treated to lower micro's and eliminate things like e-coli, salmonella, and mold is nominal compared to the potential damage allowing untreated product to go out the door. I place the blame on three equally guilty parties; the importer who bought and shipped this product without testing or probably not requiring testing at the shipping point, Wholesome spice for selling product that they did not take due care to make sure micro's were within acceptable specification from ASTA (American Spice Trade Assoc), and Daniele's for accepting inferior product probably due to price considerations and not requiring COA's (Certificate of Analysis) that would show testing for and reduction of salmonella

This is products liability 101 with a good dose of concern for public health.  Well said.

Salami/Pepper Salmonella outbreak: FSIS updated list of implicated retail locations

Updated list of retail locations who may have received Salmonella-contaminated sausage products, including salami/salame, from Daniele International, Inc.:

1.  Albertsons:  AZ, CO, ID, LA, MT, NM, OR, TX, UT, WA, WY

2.  Beverages & More:  CA

3.  Bi-Lo:  SC, TN

4.  BJ's:  All stores nationwide

5.  Bloom:  MD, NC, SC, VA

6.  Bottle King:  NJ

7.  Brookshire Bros.:  TX

8.  Costco:  All stores nationwide

9.  D'Agostino Supermarket:  NY

10.  Dave's Market:  RI

11.  Earth Fare:  NC, TN

12.  Food Emporium:  NJ

13.  Fred Meyer:  AK, ID, OR, WA

14.  Fresh Fields:  TX

15.  Fry's Food and Drug/Fry's Marketplace:  AZ

16.  Giant Food Store:  MA, PA, VA, WV

17.  Haggen:  OR, WA

18.  Harris Teeter:  DC, DE, MD, NC, SC, TN, VA

19.  Hilander:  IL

20.  Kings:  NJ, PA

21.  Kroger:  AL, GA, IL, IN, KY, PKG, LA, MI, MO, NC, OH, SC, TN, TX, VA, WV

22.  Market Basket:  MA, NH, NJ

23.  Martins Food Market:  MD, PA, VA, WV

24.  Pathmark:  NJ, NY, PA

25.  Piggly Wiggly:  SC

26.  Quality Food Center/QFC-Fresh Fare:  OR, WA

27.  Ralphs/Ralphs Fresh Fare:  CA, NY

28.  Roche Bros.:  MA

29.  Sams Club:  All stores nationwide

30.  Scotts:  IN

31.  Shoppers Market:  MD, VA

32.  Shop-Rite:  NJ

33.  Smith's/Smith's Marketplace:  AZ, ID, MT, NM, NV, UT, WY

34.  Stop and Shop/Super Stop and Shop:  CT, MA, NH, NJ, NY, RI

35.  Super K-Mart:  IL, IN, MI, NY, OH, PA, SC

36.  The Fresh Market:  NC

37.  Top Food:  WA

38.  Waldbaums:  NY

39.  Walmart:  All stores nationwide

40.  Wegmans:  NY

41.  Weis:  MD, NJ, NY, PA

42.  Whole Foods:  TX

Salmonella salami outbreak update: Daniele, Inc. says it was the pepper after all

Today Daniele, Inc. announced that tests have confirmed the presence of salmonella in the black pepper that the company used to coat the salami product that has been implicated in a massive national salmonella outbreak. The outbreak, which has sickened at least 189 people in 40 states, involves multiple strains of Salmonella bacteria. Today’s announcement confirms what Daniele, Inc. seems to have suspected since announcing the recall back on January 23, 2010.

But the announcement also leaves some major questions unanswered, like who was the supplier of the contaminated pepper?  FSIS, FDA, and CDC have not acted promptly enough in informing the public about the circumstances of this outbreak and recall, so Daniele, Inc. should take the initiative in the name of public health and tell the public who supplied it with contaminated pepper. At this point, for all we know, the pepper could be in the homes of many people across the country.

Also, outbreaks linked to pepper are by no means a new phenomenon. In August 2008 the Canadian Food Inspection Agency (CFIA) and Pak National Foods Limited warned the public not to consume the National Black Pepper Powder because the product may have been contaminated with Salmonella. The product had been distributed in Alberta and British Columbia. The importer, Pak National Foods Limited, Richmond, British Columbia, voluntarily recalled the affected product from the marketplace.

In March 2009, a Northern California company recalled two product lines: "Uncle Chen" white and black peppers and "Lian How" dry spices, after health officials identified Lian How-brand white pepper as the culprit in a recent Salmonella outbreak. At least 42 people had fallen sick in the four-month outbreak. Three other states besides Washington have were also involved in the outbreak: California, Nevada and Oregon.

And in August 2009 Adams Extract and Spice announced a voluntary recall of products because they had the potential to be contaminated with Salmonella. The products contained a specific lot of ground red pepper supplied by Van de Vries Spice Corporation. This lot of ground red pepper initially tested negative for Salmonella. Subsequently, Adams Extract and Spice was informed that another sample drawn from the same lot was confirmed positive for Salmonella.
 

Washington and California hit hard in Salami Salmonella outbreak

Winter 2010 is shaping up to be a rough one for West Coast residents, who are often insulated from the weather woes of the rest of the country.  Southern California has been hammered by constant rain causing mudslides, evacuations, and any number of other weather-induced perils.  Meanwhile, Salmonella bacteria have been finding their way into the homes of many California residents for months now.  The vehicle, of course, is salami produced by Daniele, Inc., a Rhode Island company, and at least 30 California residents (and that's only the confirmed cases) have been sickened.  Washington residents have not fared much better.  At least 14 people from the State have been sickened in the outbreak. 

Here is the CDC's map showing the distribution of recognized cases nationally:

Link to the CDC's interactive map. 

As of 9:00 pm EST on January 24, 2010, a total of 187 individuals infected with a matching strain of Salmonella Montevideo have been reported from 39 states since July 1, 2009. The number of ill persons identified in each state with this strain is as follows: AL (2), AZ (5), CA (30), CO (3), CT (4), DE (2), FL (2), GA (3), IA (1), IL (11), IN (3), KS (3), LA (1), MA (12), MD (1), ME (1), MI (1), MN (4), MO (1), NC (9), ND (1), NE (1), NH (1), NJ (7), NY (15), OH (9), OK (1), OR (8), PA (3), RI (2), SC (1), SD (3), TN (4), TX (7), UT (7), VA (1), WA (14), WV (1), and WY (2).