Food Poisoning Lawyer & Attorney : Marler Clark : Food Poison Journal

1.  Salmonella outbreak linked to Daniele Inc salami products, and, ultimately, to contaminated red and black pepper from Wholesome Spice Company and Overseas Mincing Spice Company.  252 people sickened in 44 states and the District of Columbia.

2.  Shigella outbreak linked to Lombard, Illinois Subway restaurant.  Hundreds ill.

3.  E. coli O111 outbreak linked to food served at Colorado prison.  At least 11 ill.

4.  E. coli O145 outbreak linked to common food item served in Ohio and Michigan.  47 confirmed illnesses; victims still being counted.

These are just a few examples of food safety events (or failures) in 2010.  In addition, one of the largest food recalls in history has occurred this year, concerning hydrolyzed vegetable protein (HVP) from Basic Flavors Foods in Nevada.

Meanwhile, S 510, the important food safety legislation that the House passed last year, sits mired in the Senate, awaiting debate and a vote.  The Food Safety Modernization Act would amend the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the authority of the Secretary of Health and Human Services (the Secretary) to regulate food, including by authorizing the Secretary to suspend the registration of a food facility.

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The outbreak linked to salami and pepper, and the recall linked to hydrolyzed vegetable protein (HVP), have sparked additional food recalls.  First, the pepper.  The FDA's recall notice posted today (it is dated March 25th--from a consumer health standpoint, shouldn't these notices be going up a little closer in time to the day they occurred) states as follows:

As a result of a nationwide recall of Black Pepper by Mincing Overseas Spice Company and by Dutch Valley Food Distributors, Perfect Candy & Packaging Co is joining in this product recall 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,. 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.

Perfect Candy & Packaging Co. has issued a voluntary recall for the following product with an H.D.W. Foods Inc. label.

Whole Black Peppercorns, 2.0 oz Bags UPC# 080869654293

And the HVP recall notice (again, dated March 25 but posted today--I check multiple times a day) states:

Modern Products, Inc. is initiating a recall of products manufactured with HVP (Hydrolyzed Vegetable Protein) supplied by Basic Food Flavors of Las Vegas, Nevada, because the ingredient has the potential to be contaminated with Salmonella.

"Consumption of products containing Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. 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."

To date, no illnesses have been associated with any Modern Products seasonings. In addition, random samples covering all HVP batches of concern were sent to an independent laboratory for testing and all results came back negative, but to be safe, FDA's recommendation to recall product is being followed. 

The CDC's outbreak summary indicates that , 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 from Wholesome Spice Company and Mincing Overseas Spice Company.  See summary and other commentary on outbreak.

The original HVP recall occurred last month and was initiated by Basic Food Flavors, a Las Vegas, Nevada company.  HVP is a flavor enhancer used in a wide variety of processed food products, such as soups, sauces, chilis, stews, hot dogs, gravies, seasoned snack foods, dips, and dressings. The FDA recently announced that, during its investigation at the Las Vegas facilities of Basic Food Flavors, it found Salmonella Tenessee (the serotype involved in the recall) in the companies production equipment. “This situation clearly underscores the need for new food safety legislation to equip FDA with the tools we need to prevent contamination," said Dr. Jeff Farrar, associate commissioner for food protection, FDA’s Office of Foods.

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Yesterday, yet another company announced a recall of products containing black pepper sold by Mincing Overseas Spice Company.  The company that announced yesterday's recall is John B. Sanfilippo and Sons, from Elgin, Illinois.  The FDA's recall notice states as follows:

As a follow up to the voluntary recall of black pepper from Mincing Overseas Spice Company announced on March 5, 2010, John B. Sanfilippo & Son, Inc. (Nasdaq: JBSS) (the "Company") announced today that it is voluntarily recalling various snack mix and cashew products, which have been flavored with seasoning containing the recalled black pepper and which are listed below, as a precautionary measure because the product may be contaminated with Salmonella

Does Mincing Overseas Spice Company have problems with traceability?  See Delays in Pepper Recalls Threaten Public Health.  Will punitive damages be assessed against Mincing in lawsuits against it in the pepper outbreak?  After all, pepper has been known to have been the source of the large national Salmonella outbreak associated with Daniele Inc. salami since late January.  How many people have needlessly become ill as a result of consuming pepper products that should have been taken out of distribution weeks, if not months, ago?

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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?

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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.

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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.

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In the midst of ongoing salmonella and listeria outbreaks involving red pepper/black pepper/salami and Queseria Bendita cheese, we will file a lawsuit tomorrow in Oakland on behalf of the family of an elderly woman who died in April 2009 after ingesting white pepper contaminated by Salmonella rissen bacteria.  The defendants are the companies that manufactured and distributed the contaminated product.  It is apparent from the FDA's investigation records, and from letters the FDA sent to Union International, the spice company that manufactured the contaminated product, that the production environment had many critical food handling and production problems that contributed to the outbreak.  

During the FDA's inspection of Union International, fourteen swabs taken from different locations at the production facility tested positive for Salmonella.  Regarding the concerning findings, the FDA advised the company in a November 24, 2009 letter sent to Daniel Chen, Vice President & Manager, that:

Each of these positive subsamples was further serotyped and determined to be S. rissen, the same serotype with an indistinguishable Pulsed-Field Gel Electrophoresis (PFGE) pattern as isolated from the samples of finished product. Finding Salmonella very near to where food is exposed indicates a high risk of product contamination. Based on our analytical and inspectional findings, your firm's pepper and other spice products are adulterated within the meaning of Section 402(a)(4) of the Act, [21 U.S.C. § 342(a)(4)],

Further, serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations (CFR), Part 110 (21 CPR 110), including possible routes of cross-contamination, were identified by our investigators

This letter may not list all the violations at your facility. You are responsible for ensuring that your establishment operates in compliance with the Act and the CGMP regulation (21 CFR Part 110). Failure to implement lasting corrective action of these violations and prevent their recurrence may result in regulatory action being initiated by FDA without further notice. The Act authorizes injunctions against manufacturers and distributors of illegal products, and the seizure of such products, under sections 302 and 304 [21 U.S.C. §§ 332 and 334]. In addition, section 303(a)(1) of the Act [21 U.S.C. § 333(a)(I)] provides that there is criminal liability for all violations of the prohibited acts described in section 301 of the Act [21 U.S.C. § 331].

The company immediately acted to correct the violations, but not before a lot of people were sickened in a major outbreak in the western United States.  Suit will be filed tomorrow on behalf of a woman who died as a result of Union International's and supplier's mistakes.

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In order to aid consumers, the Food Safety and Inspection Service of the U.S. Department of Agriculture has consolidated into this one list all the of ready-to-eat Italian deli meats and sausages currently subject to recall by Daniele International Inc.

On January 23, 2010 and in an update on February 4, 2010, Daniele International Inc., an establishment with operations in Pascoag and Mapleville, R.I., recalled 1,263,754 pounds of the following 20 products:

3-ounce packages of "DANIELE NATURALE SALAME COATED WITH COARSE BLACK PEPPER."
 

Approximately 6-pound packages of "DANIELE SALAME GRANDE COATED WITH PORK FAT & PEPPER."

10-ounce packages of "DANIELE NATURALE SALAME COATED WITH COARSE BLACK PEPPER."
Catch weight packages of "DANIELE PEPPER SALAME."

9-ounce packages of "BLACK BEAR OF THE BLACK FOREST BABY GENOA PEPPER SALAME."

20-ounce packages of "DANIELE DELI SELECTION, GENOA SALAME, SMOKED SALAME, PEPPERED SALAME, RUSTIC SALAME."

340- and 454-gram packages of "DANIELE SURTIDO FINO ITALIANO, SALAMI GENOA CON PIMIENTA, LOMO CAPOCOLLO, SALAMI CALABRESE."

16-ounce packages of "DANIELE ITALIAN BRAND GOURMET PACK, HOT CALABRESE, PEPPER SALAME, HOT CAPOCOLLO."

8-ounce packages of "DIETZ & WATSON ARTISAN COLLECTION PARTY PLATTER PACK, HOT CALABRESE, PEPPER SALAME, HOT CAPOCOLLO."

8-ounce packages of "DANIELE ITALIAN BRAND GOURMET PACK, HOT CALABRESE, PEPPER SALAME, HOT CAPOCOLLO."

16-ounce packages of "DANIELE GOURMET COMBO PACK, PEPPER SALAME, CAPOCOLLO, CALABRESE."

500-gram packages of "DANIELE ITALIAN BRAND GOURMET PACK EMBALLAGE ASSORTI GOURMET ITALIEN, HOT CALABRESE, PEPPER SALAME, CALABRESE PIQUANT, SALAMI AU POIVRE, HOT CAPOCOLLO, CAPOCOLLO PIQUANT."

8-ounce packages of "BOAR'S HEAD BRAND ALL NATURAL SALAME COATED WITH COARSE BLACK PEPPER."

Catch weight packages of "DIETZ & WATSON ARTISAN COLLECTION, BABY GENOA PEPPER SALAME, MADE WITH 100% PORK COATED WITH BLACK PEPPER AND PORK FAT."

20-ounce variety packages of "DANIELE DELI SELECTION, GENOA SALAME, SWEET SOPRESSATA, PEPPERED GENOA, MILANO SALAME."

21-ounce variety packages of "DANIELE GOURMET ITALIAN DELI SELECTION, SWEET SOPRESSATA SALAMI, PEPPERED GENOA SALAMI, HOT SOPRESSATA SALAMI, MILANO SALAMI, SALAMI SOPRESSATA DOUX, SALAMI GENOA POIVRÉ, SALAMI SOPRESSATA PIQUANT, SALAMI MILANO."

7-ounce packages of "DANIELE SALAME BITES PEPPER SALAME."

14-ounce packages of "DANIELE GOURMET ITALIAN DELI SELECTION ASSORTMENT DE FINES CHARCUTERIE ITALIENNE, SWEET SOPRESSATA SALAMI, MILANO SALAMI, SALAMI SOPRESSATA DOUX, SALAMI MILANO."

Catch weight packages of "DANIELE NATURALE SALAME COATED WITH COARSE BLACK PEPPER."

32-ounce variety packages of "DANIELE DELI SELECTION, GENOA SALAME, SWEET SOPRESSATA, PEPPERED GENOA, MILANO SALAME."

Each package bears a label with establishment number "EST. 9992" or "EST. 54" inside the USDA mark of inspection. The establishment is recalling all the products listed above which are currently in commerce. These products were distributed to retail establishments nationwide, as well as internationally.

On January 31, 2010, Daniele International Inc. expanded the recall to include 17,235 pounds of the following three products:

Packages of "DANIELE HOT SOPRESSATA CALABRESE," produced on 11/7/09, 12/16/09 and 12/18/09.

Packages of "DANIELE SOPRESSATA CALABRESE," produced on 12/16/09 and 12/18/09.

Packages of "BOAR'S HEAD BRAND HOT SOPRESSATA CALABRESE," produced on 11/28/09, 12/9/09 and 12/14/09.

Each package bears a label with establishment number "EST. 54" inside the USDA mark of inspection and weighs approximately 3 to 3.5 pounds. These products were distributed to retail establishments nationwide.

On February 16, 2010, Daniele International Inc. expanded the recall to include 115,000 pounds of the following seven products:

8-ounce packages of "DANIELE HOT SALAME PANINO WITH FRESH MOZZARELLA."

8-ounce packages of "BOAR'S HEAD SALAME PANINO, SALAME ROLLED IN MOZZARELLA CHEESE."

8-ounce packages of "DANIELE ITALIAN STYLE SALAME PANINO, HOT SALAME ROLLED IN MOZZARELLA CHEESE."

Random weight packages of "DANIELE ITALIAN STYLE SALAME PANINO, HOT SALAME ROLLED IN MOZZARELLA CHEESE."

8-ounce packages of "DIETZ & WATSON ARTISAN COLLECTION HOT SALAME PANINO, HOT SALAME ROLLED IN MOZZARELLA CHEESE."

8-ounce packages of "DANIELE SALAME PANINO WITH FRESH MOZZARELLA AND BASIL."

1-pound 8-ounce variety packages of "DANIELE CAPOCOLLO PANINO WITH FRESH MOZZARELLA AND BASIL; PRESIDENT'S PROSCIUTTO PANINO WITH FRESH MOZZARELLA AND BASIL; HOT SALAME PANINO WITH FRESH MOZZARELLA," with UPC Code 736436709582.

NOTE: The products contained in this variety three-pack may be sold individually as well.
Each package bears a label with establishment number "EST. 459" inside the USDA mark of inspection. The above products are sold individually packed, except as noted above. The products subject to recall have sell-by dates ranging from February 3, 2010, through May 26, 2010, and were distributed to retail establishments nationwide.
 

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In a statement released today, Daniele Inc. indicates that the black and red pepper that was included in its recalled salami products came from the same supplier,  The statement reads, in part, as follows:

On February 16, 2010, Daniele expanded this recall because of concerns about red pepper used at one
of its plants. The company voluntarily recalled 115,000 pounds of its Hot Salame Panino product
produced between November 5, 2009 and February 15, 2010. The red pepper used on this product came
from the same supplier that provided Daniele with black pepper that also tested positive for salmonella.
Daniele has terminated its relationship with the supplier and is now using only irradiated pepper.

This is useful information in the context of what is clearly a continuing investigation into an ongoing public health event.  Daniele indicates in the statement that yesterday's expansion of its recall included products produced between November 5, 2009 and February 15, 2010.  With a last production date, based on information known now, just a couple of days ago, this timely information hopefully will be crucial in preventing some illnesses. 

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The CDC now counts 217 confirmed cases in the Salmonella montevideo outbreak linked to contaminated salami and pepper. 

As of 9:00 pm EST on February 8, 2010, a total of 217 individuals infected with a matching strain of Salmonella Montevideo 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 (5), CA (30), CO (4), CT (5), DC (1), DE (2), FL (3), GA (3), IA (1), ID (2), IL (14), IN (3), KS (3), LA (1), MA (12), MD (1), ME (1), MI (4), MN (5), MO (1), MS (1), NC (9), ND (1), NE (1), NH (1), 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 (15), WI (1), WV (1), and WY (2).

This outbreak was originally announced back on January 23, which is also the day that Daniele Inc recalled 1,240,000 pounds of salami products potentially contaminated by Salmonella.  Daniele later expanded the recall by over 17,000 pounds.  The products were distributed nationally and sold at many retail grocery outlets. 

Outbreak summary:  the 217--a number that will likely continue to grow--confirmed illnesses that the CDC has linked to the outbreak have occurred in 44 different states.  The Daniele Inc recalled salami product was contaminated with multiple strains of Salmonella, including montevideo.  There has been no official announcement of the other strains of salmonella involved in the outbreak.  We also know that the actual outbreak vehicle was the black pepper that was used to coat the recalled salami products.  Daniele purchased the contaminated pepper from two companies, Wholesome Spice and Overseas Spice Company.  Samples from unopened containers of pepper from both companies have tested positive for Salmonella. 

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We are currently investigating the illnesses of 15 people potentially sickened by Salmonella-contaminated Salami.  There is the possibility, as well, that other products are contaminated by Salmonella montevideo or other strains of salmonella, yet we know virtually nothing about the whereabouts of the pepper.  We were contacted yesterday by a young woman from Washington sickened in late January 2010 . . . after the Daniele Inc recall of 1.2 million pounds of potentially contaminated salami.  She bought the salami at Costco, but didn't consume it until after word of the outbreak and recall had been announced.  She just didn't know that the outbreak was occuring.

Had more effort been put forth to make people aware of the outbreak and dangers associated with consuming the implicated product, this woman's illness may not have happened, and she would not now be in danger of losing her job because of missed work days due to illness.  This outbreak is associated with a product--actually two products, pepper and salami--with very long shelf lives.  In such a situation, where there is more than a slim possibility that contaminated product will stay in people's homes well past public announcement of an outbreak or recall, better effort and more resources need to be devoted to informing the public of the risks they face. 

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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. 

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The CDC has again revised its numbers in the Salmonella montevideo outbreak linked to Daniele Inc. salami and black pepper sold by Oversees Spices Company and Wholesome Spice.  There are currently 213 cases nationwide, stretching from July 2009 to the present.  California Washington, Illinois, and Massachussetts remain the hardest hit states, with 30, 15, 13, and 12 cases respectively. 

This outbreak has been thought provoking to say the least.  It highlights the need for better communication amongst public health agencies, and faster dissemination of crucial information to the public.  See The slow flow of information about food outbreaks.  It is also remarkable for its length, causing illnesses over at least a seven month period, and it remains to be seen whether the outbreak is even over.  Rhode Island has detected Salmonella in the black pepper sold to Daniele Inc by Oversees and Wholesome, and we still have no word on whether the contaminated black pepper is in consumers homes, on store shelves, or in other food products around the country. 

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Today, the Rhode Island Department of health announced that the pepper that Daniele Inc used to produce its salami--now the subject of a major recall and outbreak--was contaminated, not the meat itself   Pepper has been suspected as the source of this outbreak since at least January 23, 2010, if not before.  A little frighteningly, Rhode Island also says that pepper from both of Daniele Inc's suppliers has tested positive for the outbreak strain (suggesting a common grower or shipper) of salmonella, and that a number of outbreak victims may not have eaten salami at all.  What's the implication?  That more than just Daniele Inc. has received contaminated  black pepper.  Is it in your home now?

The problem that this scenario brings to light is that the public is clearly not getting the information that it should . . . and in a timely fashion.  As I posted earlier today, the suppliers of pepper to Daniele (Oversees Spice Company and Wholesome Spice) should publicly disclose the list of customers who bought, or may have bought, the contaminated pepper.  After all, the fact that some of the people sickened with the outbreak strain of salmonella in this outbreak, and who did not have an exposure to salami, suggests that other food producers may in fact have received the contaminated pepper as well, and they may be producing and selling food that is contaminated.  Maybe the FDA doesn't have enough information to establish just who that or those food producers are, but Oversees and Wholesome could certainly protect a lot of people by disclosing their customer list. 

This problem--i.e. the stagnant flow of information in food outbreaks--is not all on food suppliers either.  Timely information published in a manner that effectively passes the information to the consuming public is not a strong point of our government either.  Bill Marler authored a highly insightful blog post several days ago about this problem.  Asking "why the silence of the steaks and the perjury of the peppers," he stated as follows:

why do the US Government and US Business not believe in Capitalism? The one thing that makes capitalism – free markets – work is knowledge and transparency. If you know who poisoned you, you can stop buying food from them. However, here – especially here – the government and industry do everything they can to not tell us the facts. In both instances they put the information out on a holiday or a Friday night, so no one but a loser blogger would be paying attention. More importantly is the fact that they withhold information about the ultimate source of the contamination? Why not say whom the supplier of steaks and trim is? Why not let the public know who produced the peppers and where they are from?

As for steaks, the event that got Bill talking was the recall of 124 tons of tenderized beef products manufactured by National Steak and Poultry and sold to a variety of major restaurant chains throughout the country.  The recall was announced by USDA's Food Safety and Inspection Service on . . . Christmas Eve.  Other than a few lawyers and the CDC, who is paying attention to FSIS recall notices on Christmas Eve?  Or the following day?  Or really any day for the rest of the year?  And for that matter, on New Year's day too?  Virtually nobody, particularly not a very significant percentage of the food consuming public. 

This kind of information should not come on Christmas Eve, Friday night, or any other time of the year clearly designed to lessen the flow of information to the public, thereby protecting the interests only of the business that manufactured or sold the contaminated product.  Eddie Gehman Kohan said it much better on her blog, Obamafoodorama.com, posing the question "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?":

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).

If the answer to these valid questions is that notifying the public will encourage lawsuits, or make them easier to prove, the failure to do so is only going to allow outbreaks to happen.  And that's when the lawyers come in. 

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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?

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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.

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Tomorrow morning, we will file a second lawsuit in the Salmonella outbreak linked to recalled salami (Daniele, Inc.) and pepper (Wholesome Spice).  The lawsuit will be filed on behalf of Lee Hanks, a resident of Lake Ozark, Missouri. 

Lee purchased the contaminated salami on January 17, 2010, at a WalMart store in Osage Beach, Missouri.  The Salmonella contaminated salami was one part of a variety package of Daniele Inc salami products.  At least one of the salami varieties contained pepper manufactured by defendant Wholesome Spice.

Lee Hanks consumed pieces of the contaminated salami the next day and fell ill late the same evening.  Symptoms began with cramps and nausea. Lee woke up in the early morning hours of January 19, 2010, feeling extremely nauseated, with alternating chills and fevers, and suffering from explosive bouts of diarrhea.

Lee's illness worsened over the next 48 hours, causing him to call his primary care physician the afternoon of Thursday, January 21, 2010. His physician prescribed anti-diarrheal and anti-nausea medications. Lee immediately began to take the medications that his doctor had prescribed, but he only became more ill, weak, and disoriented. Finally, on Saturday, January 23, 2010, Lee had become so ill that his wife demanded that he go to the emergency department at Lake Regional Hospital in Osage Beach, Missouri.

At the emergency department, Lee received several liters of fluid to correct his severe dehydration. He also received a potassium supplement, as his severe gastrointestinal losses had caused him to develop hypokalemia. Lee's attending physician ultimately diagnosed him with a severe bacterial infection and prescribed the antibiotic ciprofloxacin. And before being discharged, Lee submitted a stool sample for testing. 

Lee Hanks continued to be extremely ill and weak over the course of the next several days. The frequent bouts of diarrhea finally began to slow on or about Monday afternoon, but Lee continues to suffer from gastrointestinal discomfort as a result of his Salmonella infection.

In discussions with health officials from Miller County and the State of Missouri, Lee earned that the stool sample he submitted while at the emergency department tested positive for Salmonella Montevideo, which is the strain involved in the national outbreak linked to Defendants’ salami and pepper products.

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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.

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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

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