The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) is announcing that it will be declaring Salmonella an adulterant in breaded and stuffed raw chicken products.

“Food safety is at the heart of everything FSIS does,” said Agriculture Secretary Tom Vilsack. “That mission will guide us as this important first step launches a broader initiative to reduce Salmonellaillnesses associated with poultry in the U.S.”

“Today’s announcement is an important moment in U.S. food safety because we are declaring Salmonella an adulterant in a raw poultry product,” said Sandra Eskin, USDA Deputy Under Secretary for Food Safety. “This is just the beginning of our efforts to improve public health.”

By declaring Salmonella an adulterant in these products, FSIS will be able to ensure that highly contaminated products that could make people sick are not sold to consumers. Since 1998, breaded and stuffed raw chicken products have been associated with up to 14 outbreaks and approximately 200 illnesses. Products in this category are found in the freezer section and include some chicken cordon bleu or chicken Kiev products. These products appear cooked, but they are heat-treated only to set the batter or breading and the product contains raw poultry. Continual efforts to improve the product labeling have not been effective at reducing consumer illnesses.

Breaded and stuffed raw chicken products will be considered adulterated when they exceed a very low level of Salmonella contamination and would be subject to regulatory action. FSIS will be proposing to set the limit at 1 colony forming unit (CFU) of Salmonella per gram for these products, a level that the agency believes will significantly reduce the risk of illness from consuming these products. The agency will also seek comment on whether a different standard for adulteration – such as zero tolerance or one based on specific serotypes – would be more appropriate.

The notice is expected to publish in the Federal Register in the fall and FSIS will be seeking public comments that address what the standard should be as well as to inform a final implementation plan, including a verification testing program. Once published, the notice will be posted in FSIS’ Federal Register & Rulemaking page for review and comment. When the proposal is finalized, FSIS will announce its final implementation plans and the date it will begin routine testing for Salmonella in these products.

This action is part of FSIS’ broader efforts to reduce Salmonella illnesses associated with poultry. In October 2021, USDA announced it was reevaluating its strategy for controlling Salmonella in poultry, including whether Salmonella should be considered an adulterant in specific raw poultry products. Since launching this effort, USDA has been focusing on gathering information by meeting with stakeholders to hear their ideas, asking for recommendations from food safety experts, and soliciting ideas for pilot projects from industry to test drive different control strategies in poultry establishments. USDA plans to present a proposed framework for a new comprehensive strategy to reduce Salmonella illnesses attributable to poultry in October and convene a public meeting to discuss it in November.

As I said in a post a few months ago, calling the obvious the obvious is not a bad thing.

If Salmonella is deemed an adulterant – at least those that sicken and kill us – the sky will not fall – history as a guide.

On Jan. 19, 2020, we filed a petition with USDA’s Food Safety and Inspection Service (FSIS), on behalf of Rick Schiller, Steven Romes, the Porter family, Food & Water Watch, Consumer Federation of America, and Consumer Reports. 20-01-marler-011920 The petition asked FSIS to declare the following Salmonella “outbreak serotypes” as per se contaminants (adulterants) in meat and poultry products:

Salmonella Agona, Anatum, Berta, Blockely, Braenderup, Derby, Dublin, Enteritidis, Hadar, Heidelberg, I 4,[5],12:i:-, Infantis, Javiana, Litchfield, Mbandaka, Mississippi, Montevideo, Muenchen, Newport, Oranienburg, Panama, Poona, Reading, Saintpaul, Sandiego, Schwarzengrund, Senftenberg, Stanley, Thompson, Typhi, and Typhimurium.

I said at the time, reducing salmonellosis from meat and poultry “demands bold action” beyond that yet taken by FSIS. Salmonella is a leading cause of foodborne illness in the United States, causing 1.35 million illnesses, 26,500 hospitalizations, 130 outbreaks, and 420 deaths each year.

Presently, government regulators are somewhat silent with what they intend to do.  The poultry industry, as expected, sees any additional regulation as unnecessary, burdensome and costly.

This is nothing new.   Here is a historical piece written by Helena Bottemiller, then at Food Safety News:

It was Sept. 29, 1994. Mike Taylor took the podium in San Francisco at the American Meat Institute’s annual convention to make his first, and most significant, speechas the top food safety official at the U.S. Department of Agriculture.

“I am here to talk about change,” began Taylor, who had just become administrator for the USDA’s Food Safety Inspection Service, as he looked out over his all-industry audience. “Change in what the public expects when it comes to food safety, change in how we at the Food Safety and Inspection Service (FSIS) are approaching our job, and change in the demands being placed on all those who produce, process and market meat and poultry for American consumers.”

Taylor explained his belief that the meat industry had an opportunity to move beyond the politics of food safety and find real solutions on the heels of the massive E. coli O157:H7 outbreak in the Pacific Northwest.

“You know from your daily experience that improving food safety serves us all.”

And then, Taylor uttered a few lines the industry may not have wanted to hear:

“In one critical respect, our inspection program at FSIS does not currently meet the public expectation. There is a gap in our system…”

“The fact is we do not deal directly enough and scientifically enough with the microbial pathogens that can make people sick,” he continued, before outlining some sweeping public health goals. And then he got very specific.

“To clarify an important legal point, we consider raw ground beef that is contaminated with E. coli O157:H7 to be adulterated within the meaning of the Federal Meat Inspection Act,” he added, explaining that he wanted to make USDA’s E. coli policy “crystal clear.”

“We are prepared to use the Act’s enforcement tools, as necessary, to exclude adulterated products from commerce.”

In September 2011, FSIS banned the “the Big Six” as reported by Helena Bottemiller, still then at Food Safety News:

Six dangerous strains of E. coli — dubbed “the Big Six” — will soon be banned from the beef supply, U.S. Department of Agriculture officials said Monday.

“This is one of the biggest steps forward in the protection of the beef supply in some time,” Under Secretary for Food Safety at USDA, Dr. Elisabeth Hagen, told the New York Times. “We’re doing this to prevent illness and to save lives.”

The proposal, which will be outlined in more detail by top USDA officials Tuesday morning, will declare six additional strains of Shiga toxin-producing E. coli (STECs), beyond well-known E. coli O157:H7, as adulterants in beef, making product contaminated with these pathogens illegal to sell in commerce. USDA’s Food Safety and Inspection Service will soon test ground beef, beef trim that goes into ground beef, and machine-tenderized steaks for these pathogens.

E. coli O157:H7 has been illegal in beef products since 1994, a policy that was put in place in response to the historic outbreak that sickened hundreds and killed four children in the Pacific Northwest. The new policy, which will extend to E coli O26, O45, O103, O111, O121, and O145, is expected to kick in in March.

The meat industry did not react warmly to the announcement, while consumer groups unanimously praised the move.

“USDA’s announcement today that it will soon be ‘illegal’ to have six strains of naturally occurring non-O157 E. coli in ground beef is premised upon the notion that the government can make products safe by banning a pathogen,” said James H. Hodges, executive vice president of the American Meat Institute, the group representing the vast majority of the meat industry. “That view is not supported by science.”

AMI believes the interventions currently used to eliminate E. coli O157:H7 will work for the non-O157 strains and slammed USDA for adding costs that it said will eventually be passed along to consumers.

 “USDA will spend millions of dollars testing for these strains instead of using those limited resources toward preventive strategies that are far more effective in ensuring food safety,” added Hodges, in a statement to reporters. “Imposing this new regulatory program on ground beef will cost tens of millions of federal and industry dollars – costs that likely will be borne by taxpayers and consumers.  It is neither likely to yield a significant public health benefit nor is it good public policy.”

Food safety advocates, many of whom have been lobbying USDA to take action on non-O157 E. coli strains for years, lauded the announcement and argued that the policy may well help the meat industry by preventing costly recalls.

“This is a huge step,” said Dr. Barbara Kowalcyk, CEO of the Center for Food Borne Illness Research and Prevention, who became a tireless advocate after her son lost his life from an E.coli O157:H7-contaminated hamburger. “We think this is going to have a significant impact on public health — fewer recalls, fewer illnesses, fewer deaths.”

Kowalcyk believes the policy is actually a bargain, when you weigh the costs and benefits. USDA estimates that the new rule could cost the meat industry as much as $10 million annually, not just for testing but also for cooking meat that tests positive before it hits store shelves.

“The average cost of a recall is $4-5 million plus the loss in consumer confidence,” added Kowalyck. “Preventing just two recalls could make up for the cost. And that’s not even taking into account the human costs.”

According to the Centers for Disease Control and Prevention, the six strains addressed under the new regulation cause approximately 113,000 illnesses and 300 hospitalizations annually in the United States.

Nancy Donley, co-founder of STOP Foodborne Illness, whose son died in 1993 from an E. coli O157:H7 infection, was also very pleased with the announcement.

“All of us at STOP Foodborne Illness are absolutely thrilled to have the big six declared adulterants,” said Donley in an email. “It’s something that we have been advocating for years now.  We’re pleased to see the USDA act progressively in putting forward an initiative that should greatly enhance public health and safety rather than waiting for another major foodborne illness outbreak to spur them to action.”

USDA’s announcement comes two years after Bill Marler, managing partner at Marler Clark, the nation’s leading food safety law firm (and publisher of Food Safety News), petitioned the department to declare all non-O157 STECs as adulterants. Petition(with Attachments)

“I’m really pleased,” said Marler. “This is going to go a long way towards making our food supply safer.”
Congresswoman Rosa DeLauro (D-CT), a staunch supporter of tougher food safety laws, echoed the praise, saying she was “thrilled” by the decision.
“It is a critical step forward in bettering our food safety system,” said DeLauro in a statement. “When a similar action was taken on E. coli O157:H7, its prevalence decreased by nearly fourfold, and I hope to see a similar result with these six strains. I applaud this new rule, and hope to continue enhancing the USDA’s ability to protect American consumers from unsafe food.”

If Salmonella is deemed an adulterant – at least those that sicken and kill us – the sky will not fall – history as a guide.

From the Jack in the Box E. coli outbreak in 1993 to the ConAgra E. coli outbreak in 2002, about 90% of my law firm revenue was E. coli O157:H7 cases linked to hamburger.  Deeming E. coli O157:H7 an adulterant did not change things overnight, but the government, industry and consumers over that decade worked hard to “Put me out of Business, Please.”

Today, and for the last 20 years, E. coli cases – O157 and/or “the Big Six”- linked to hamburger has been a small and diminishing factor in my practice.  It works – ask my accountant.