Does it matter that USDA/FSIS has yet to declare Salmonella a per se adulterant?

Yesterday the Minnesota Departments of Health and Agriculture made the following announcement:

State health and agriculture officials said today that six recent cases of salmonellosis in Minnesota have been linked to raw, frozen, breaded and pre-browned, stuffed chicken entrees. The implicated product is Antioch Farms brand A La Kiev raw stuffed chicken breast with a U.S. Department of Agriculture stamped code of P-1358. This product is sold at many different grocery store chains.

Investigators from the Minnesota Department of Health and the Minnesota Department of Agriculture determined that six cases of Salmonella infection from August and September 2014 were due to the same strain of Salmonella Enteritidis. One person was hospitalized for their illness.

The USDA/FSIS has not yet decided to declare Salmonella to be a per se adulterant.  Setting aside for a moment that the USDA/FSIS should in fact make that declaration, now when the USDA declares a pathogen to be a per se adulterant (E. coli O157:H7 and “the Big-Six”), enforcement-action is automatic because the presence of the pathogen has been declared in advance to pose a threat to the public health. Instead of needing to establish on a case-by-case basis that an incident of contamination poses a public health threat, the fact of contamination is deemed to have already satisfied the USDA/FSIS’s burden of showing that it can take regulatory action. That is the real meaning of the following passage from the Federal Register:

Because FSIS does not recognize Salmonella as a pathogen that would ordinarily render the product injurious to health, and thus as an adulterant within the meaning of 21 U.S.C. 601(m)(1), individual Salmonella sample results will not result in regulatory control actions.[1]

In other words, the fact of an individual positive Salmonella test result will not, by itself, prompt the agency to take some sort of enforcement action.  But that does not mean that the agency cannot take enforcement action (like a recall) once other factors are considered, including whether there have been associated illnesses.  More specifically related to poultry:


(g) The term “adulterated” shall apply to any poultry product under one or more of the following circumstances:

(1) if it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance, such article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health;

Just because Salmonella has not been declared a per se adulterant, and thus presumed to present a public health risk regardless of the meat or circumstances involved, it does not follow that Salmonella is per se never an adulterant.  Recently the USDA/FSIS announced its Salmonella Action Plan, described in by an official agency press release as follows:

The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) today released its Salmonella Action Plan that outlines the steps it will take to address the most pressing problem it faces–Salmonella in meat and poultry products. An estimated 1.3 million illnesses can be attributed to Salmonella every year.

“Far too many Americans are sickened by Salmonella every year. The aggressive and comprehensive steps detailed in the Salmonella Action Plan will protect consumers by making meat and poultry products safer.” said Under Secretary for Food Safety Elisabeth Hagen.

The Salmonella Action Plan is the agency’s strategy to best address the threat of Salmonella in meat and poultry products.[2]

The USDA/FSIS has repeatedly stated that Salmonella is, in fact, a threat to the public health:

Salmonella bacteria are among the most frequently reported causes of foodborne illness. In December 2011, a multi-state outbreak linked to a multi-drug resistant strain of Salmonella sickened 19 people in the Northeast United States[.[3]] In June 2012, FSIS was notified of a cluster of Salmonella enteriditis illnesses linked to ground beef consumption with approximately 50 case-patients across nine states[.[4]] The outbreaks referenced here and others suggest that Salmonella in ground beef is a continuing public health concern.

The changes [in FSIS Salmonella performance-standards] will likely improve FSIS’s ability to detect Salmonella by increasing the raw ground beef analytic sample portion for Salmonella analysis and increasing the number of establishments being sampled at any given time. As is also discussed below, FSIS intends to develop new performance standards that will likely lead establishments producing ground beef to strengthen their own Salmonella control measures. Such changes at establishments will likely have a positive impact on public health.

In other words, and again, the USDA/FSIS remains free to premise a whole host of regulatory and enforcement actions on the presence of Salmonella in plants or on meat, even if such actions are neither automatic nor premised on Salmonella have been already declared to be a per se adulterant. Salmonella can—and is—deemed an adulterant in plants and on meat, but only if there are facts sufficient for the bacteria to be deemed an adulterant under FMIA Section 601(m)(1), (3) or (4).

USDA /FSIS again restated its view of Salmonella as an adulterant when illnesses occur in meat products in the Federal Register discussion of HACCP Plan Reassessment for Not-Ready-To-Eat Comminuted Poultry Products and Related Agency Verification Procedures:

When NRTE poultry or meat products are associated with an illness outbreak and contain pathogens that are not considered adulterants, FSIS likely will consider the product linked to the illness outbreak to be adulterated under 21 U.S.C. 453(g)(3) or 21 U.S.C. 601(m)(3) because the product is ‘‘* * * unsound, unhealthful, unwholesome, or otherwise unfit for human food.’’ In such cases, the Agency would request that the establishment recall the product if it is still in commerce.

FSIS will also evaluate whether the particular product associated with the illness outbreak may also be adulterated because it was ‘‘* * *prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health’’ (21 U.S.C. 453(g)(4) or 21 U.S.C. 601(m)(4)). FSIS would likely find that such product is adulterated because it was produced under insanitary conditions where the establishment produced the product of concern under conditions that did not adequately address control of the pathogen in the product associated with the illness.

That Salmonella has repeatedly been treated as an adulterant is proven beyond question by the recalls that the USDA has initiated when ground beef and other products have been found to be contaminated with Salmonella. The following recalls are but a representative sample.

  • Salmonella Enteriditis Due to Contaminated Cargill Ground Beef 2012: On July 22, 2012 Cargill Meat Solutions announced a recall of 29,339 pounds of fresh ground beef products due to possible contamination with Salmonella Enteriditis.
  • Hannaford Stores Ground Beef Salmonella Outbreak 2011: A total of 16 persons infected with the outbreak strain of Salmonella Typhimurium have been reported from 7 states. Epidemiologic and traceback investigations conducted by officials in local, state, and federal public health, agriculture, and regulatory agencies linked this outbreak to eating ground beef purchased from Hannaford stores.
  • Beef Packers, Inc., Cargill, Ground Beef 2009 (two recalls): In December, Beef Packers, Inc., owned by Cargill, recalled over 20,000 pounds of ground beef contaminated with a drug-resistant strain of Salmonella Newport. The company issued an earlier recall in August 2009, due to contamination of ground beef with the same strain of Salmonella Newport.
  • King Soopers, Inc., Ground Beef 2009: King Soopers, Inc., a supermarket chain, recalled approximately 466,236 pounds of ground beef that was linked to an outbreak of Salmonella Typhimurium DT 104 in the state of Colorado.
  • Emmpak/Cargill Ground Beef 2002: In early 2002, isolates of Salmonella Newport in New York State were found to be resistant to more than nine antibiotics and had a decreased susceptibility to the antibiotic, ceftriaxone. When the cases were investigated, it was found that consumption of undercooked ground beef was the only food that was significantly associated with a risk of infection. Traceback of the meat implicated Emmpak Foods Inc., a subsidiary of Cargill, Inc.

And given that the basis for instituting a recall is a determination that “products are adulterated or misbranded under the provisions of the FMIA or the PPIA,”[5] the fact of recalls is by itself evidence that Salmonella is deemed an adulterant by the USDA on a case-by-case basis – especially when illnesses have occurred.

[1]           See 78 Fed. Reg. 53017, 53019 (August 28, 2013).

[2]           See FSIS Releases Comprehensive Plan to Reduce Salmonella (Dec. 4, 2013).

[3]           See CDC, Outbreak Report.  The USDA included a link to this CDC outbreak report as a parenthetical in the paragraph quoted above.

[5]           FSIS Directive, 8080.1, Rev. 7, Recall of Meat and Poultry Products.