January 2010

President Obama today announced his intent to nominate Dr. Elisabeth Hagen as the U.S. Department of Agriculture’s Under Secretary for Food Safety. Hagen will serve with Agriculture Secretary Tom Vilsack.

"There is no more fundamental function of government than protecting consumers from harm, which is why food safety is one of USDA’s top priorities," said

Investigation Announcement: Multistate Outbreak of Human Salmonella Montevideo Infections
Persons Infected with the Outbreak Strain of Salmonella Montevideo, United States, by State, as of January 25, 2010:

Atotal 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

The CDC has announced that 184 people have been sickened in 38 states with Salmonella Montevideo caused by “a widely distributed contaminated food product.” The FSIS and Daniele have now recalled 1,240,000 pounds of ready-to-eat varieties of Daniele Italian sausage products, including salami/salame, because they may be contaminated with Salmonella. The products were sold online

Counting Friday’s sausage recall by Daniele International, Inc., food companies have recalled at least 2,880,000 pounds of meat products since November 2009 due to contamination by E. coli or Salmonella. 

Friday’s recall:  (from FSIS press release)

Daniele International Inc., an establishment with operations in Pascoag and Mapleville, R.I., is recalling approximately 1,240,000 pounds of ready-to-eat (RTE)

We hear about them so often these days–recalls of all kinds of products, from foods, to medications, to kids toys–that "recall" has become a working concept in everybody’s vocabulary.  But what is a recall?  Who has the legal obligation to announce them?  And what legal ramifications are there ot being involved in one?  

First, despite not having the legal authority to actually recall products, the FDA and USDA are frequently involved.  In fact, the USDA’s Food Safety and Inspection Service (the agency arm responsible for ensuring the safety of meat, poultry, and eggs) sets the standards for when, and what kind of, a recall is required.  

The FSIS defines three kinds of recall actions that can fairly be included under the same umbrella.  A "Class I recall" should occur in "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."  (Editor’s note: "should" is italicized because sometimes food product manufacturers do not issue class I recalls even when circumstances require it.)  Under this definition, a Class I recall should occur any time a food product is known or suspected to be contaminated with any foodborne pathogen, whether bacterial or viral.  The reason:  bacteria and viruses make people sick, and as a result, food contaminated by them will make people sick.

A "Class II recall" should occur in "a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."  This is a little less clear than the definition of a Class I recall, but I certainly believe that the consequences of foodborne disease are simply too extreme for food companies to play fast and loose under these definitions.  A Class I recall should occur every time a food manufacturer knows, or has reason to know, that a product it has produced is or may be contaminated with a foodborne pathogen.  Every time.

Finally, a "market withdrawal"

occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.

A "market withdrawal" has no place in the world of food contamination.  Again, salmonella and e. coli and campylobacter and hepatitis and every other foodborne pathogen are simply too dangerous for companies to try to avoid their obligations by calling what should be a recall a "market withdrawal"–something done purely to avoid the media ramifications of saying that you’re product has been recalled.  This has been done before under circumstances where a Class I recall was surely warranted. Continue Reading Recall basics for food products

With the food safety spotlight currently, and squarely, on sausage (Daniele, Inc. salami linked to 184 illnesses in 38 states; at least 38 hospitalized; see FSIS press release), it might be worth the consumer’s while to spend a few minutes reviewing some sausage safety basics.  Here are some common questions and answers about sausage:

1.  Besides the manufacturer, who is responsible for ensuring the safety of sausage sold in the United States?

Answer:  Sausage is a meat product regulated by the USDA’s Food Safety and Inspection Service.  FSIS inspects all sausages in interstate commerce and all sausages that are exported to other countries. But sausages made at a retail establishment may be under the jurisdiction of that State’s health or agriculture department.

2.  Is sausage a risky food to consume?

Answer:  It depends on who you ask, but the composition and preparation of sausage might be a factor that predisposes this product to bacterial contamination.  Sausage is obviously made from a variety of meat types and cuts, and just like ground beef, there are, as a result, many critical points in the sausage-making process where adequate controls are required in order to reduce or eliminate the likelihood that the product will become contaminated.  One such control that may often be overlooked is the safety of the spices (e.g. pepper) used to enhance flavor.  NOTE:  one working theory about the Salmonella Montevideo outbreak linked to Daniele, Inc salami is that the pepper in or on the sausage was contaminated.  All the more reason for manufacturers to know, and investigate, the food safety practices of their suppliers.

3.  What must be on the label of uncooked sausages (i.e. not "ready to eat")?

Answer:  Labels for sausages that are not ready to eat must contain safe handling instructions, among other things.  Sausages that are NOT ready to eat must bear certain features such as, safe handling instructions. In cases where the sausage is partially cooked or otherwise appears cooked but requires cooking by the consumer for safety, FSIS requires additional labeling features such as a prominent statement on the principal display panel, for example, "Uncooked, Ready to cook, Cook before eating, Cook and serve" or "Needs to be fully cooked." In addition, the product should display cooking directions that are sufficient for the intended user. The manufacturer would have to validate that the cooking directions are sufficient to destroy any pathogens that could be present.

If a sausage is perishable, the label must say "Keep Refrigerated." Some federally inspected shelf-stable sausages are not ready to eat. If so, they will be labeled as above but will not have "Keep Refrigerated" on the label.Continue Reading Sausage Fact Sheet

Recall Release CLASS I RECALL
FSIS-RC-006-2010 HEALTH RISK: HIGH

Daniele International Inc., an establishment with operations in Pascoag and Mapleville, R.I., is recalling approximately 1,240,000 pounds of ready-to-eat (RTE) varieties of Italian sausage products, including salami/salame, in commerce and potentially available to customers in retail locations because they may be contaminated with Salmonella, the U.S.

Daniele, Inc. announced it is initiating a voluntary recall of its Pepper-Coated Salame products because of possible concerns about salmonella. Preliminary results indicate that eleven ill individuals had consumed salame products from "Daniele Italian Brand Gourmet Pack." State and federal health officials have been unable to confirm a direct link between the illnesses and any

From a company press release:

Daniele, Inc. announced today it is initiating a voluntary recall of its Pepper-Coated Salame products because of possible concerns about salmonella. Preliminary results indicate that eleven ill individuals had consumed salame products from "Daniele Italian Brand Gourmet Pack." State and federal health officials have been unable to confirm a direct