Strike 1.

On September 7, 2005, the Albany County Health Department (ACHD) was notified that a child was hospitalized with a diagnosis of hemolytic uremic syndrome (HUS).  Preliminary laboratory testing of the child’s stool had been conducted at St. Peter’s Hospital, and tests were originally negative for the presence of E. coli O157:H7.  ACHD arranged for the stool specimen to be sent to the New York State Department of Health (NYSDOH) Wadsworth Center for further testing.

On September 14, ACHD interviewed the child’s parents, and learned that on August 26 the child had consumed a Topps brand quarter pound beef patty that had been purchased at a Price Chopper store.  Most of the patties that came in the package of twelve frozen hamburgers had been eaten.  Two uncooked patties, however, were still in the parents’ freezer.

On September 15, the child’s stool sample results came back positive for the presence of E. coli O157:H7, and NYSDOH asked to test the leftover meat for the presence of E. coli O157:H7.    Six days later, on September 21, the NYSDOH Wadsworth Center reported that E. coli O157:H7 had been cultured in the beef patties collected from the parents’ freezer.

Pulsed Field Gel Electrophoresis (PFGE) analysis of the meat isolate and the child’s isolate showed the two were indistinguishable, confirming that the meat was the source of the child’s infection with E. coli O157:H7.  Those patties came from Topps Meat Company (“Topps”).

Strike 2 – You’re Out!

Two years later, on August 31, 2007 an online consumer complaint was filed with the USDA/FSIS after a Florida teenager fell ill after consuming a hamburger patty produced by Topps on July 12, 2007.  The 17 year old tested positive for E. coli O157:H7 on September 4, 2007.  This was followed by similar reports of illnesses connected with Topps product in New York State and elsewhere in the following days.  On or before September 8, 2007 the USDA had confirmed a sample from a Topps hamburger had tested positive for E. coli O157:H7 from the Florida teenager’s home freezer, yet no recall was begun.  Additional illnesses continued to be reported.

Topps and the USDA/FSIS took no action to remove its products from the shelves until September 25, 2007.   On that date, the USDA announced that Topps was recalling 332,000 pounds of ground beef due to contamination with E. coli O157:H7.  The initial recall encompassed only products produced on June 22, July 12, and July 23, 2007.   The New York Department of Health subsequently reported that an intact sample with a production date of June 21, 2007 had also tested positive for E. coli O157:H7.  At the same time, a USDA/FSIS conducted an inspection of Topps’ plant in Elizabeth, New Jersey.

The FSIS inspection of Topps’ plant and procedures at its Elizabeth, New Jersey facility on September 26, 2007 revealed alarming deficiencies in the firm’s safety programs.  The problems began with the raw materials.  Topps received boxed sub-primal products, which did not carry Certificates of Analysis (COA).[1]  Topps initially used these boxed sub-primal cuts only for non-ground product.   But, Topps then mixed the trim, the left-overs after butchering, with the raw materials being used for its ground beef products.  The trim was placed into the grinding operation without testing for E. coli O157:H7.  See Comprehensive Assessment of the Execution and Design of an Establishment’s Food Safety Systems.  This practice was in violation of federal regulations.  See 9 CFR 417.5 (a) 1.  The FSIS then concluded that this failure to ensure that product intended for grinding was free of E. coli O157:H7 called into question the “adequacy of the design and execution of your prerequisite program and HACCP [Hazard Analysis Critical Control Point] program.”  See Notice of Suspension.

FSIS inspectors also found various sanitation deficiencies at the facility.  During the pre-operational inspection FSIS personnel noted that “the patty making machine had gouges, cracks, and tears in the neoprene transfer belt used to move raw patties to packaging.”  The inspectors also noted a history of prior non-conformance records relating directly to raw product residue on equipment surfaces.  The FSIS concluded:

The recurring deficiencies of unsanitary equipment documented by USDA…provide evidence that [Topps] failed to re-evaluate the effectiveness of the sanitation SOPs [standard operating procedures].”

Part of the FSIS inspection included a reassessment of Topps’ HACCP plan, the plan ostensibly in place to ensure the safety of Topps’ ground beef.  FSIS reviewers found the HACCP plan severely lacking.  As an initial matter, the HACCP plan only addressed E. coli O157:H7 in one instance, identifying it simply as “a hazard not likely to occur.”   The remainder of the plan failed to address E. coli O157:H7 specifically at any other point.  FSIS also criticized Topps for failing to account for the increased prevalence of E. coli O157:H7 during the summer months, in violation of rules incorporated in 67 FR 62329.  Topps was also noted to lack documentation supporting either its sanitation or temperature control technology in violation of 9 CFR 417.5(a)(1) and 9 CFR 417.2(a)(1).  FSIS ultimately concluded that Topps had:

demonstrated a failure to adequately reassess your HACCP plan based on scientific data related to the prevalence of  E. coli O157:H7 in raw beef products and failure to support decisions that controls are in place for controlling  E. coli O157:H7 in your production process.

Not surprisingly, FSIS suspended Topps’ operations “in the interest of protecting the public’s health.”

As a result, on September 29, 2007, Topps finally expanded its recall to include a total of approximately 21.7 million pounds of frozen ground beef due to contamination with E. coli O157:H7.  The recall included all produces with un-expired sell by dates.  Ultimately, the Topps’ ground beef was linked to at least 25 E. coli O157:H7 infections in Connecticut, Florida, Indiana, Maine, New Jersey, New York, Ohio and Pennsylvania.  See CDC Outbreak Investigation File.

And, shortly after that Topps, a company in business for some 75 years, closed its doors for good.

This is another it what will be a long – too long – series of outbreak investigations where we have represented consumers in what I hope will be a cautionary tale, and a learning experience, for manufacturers of food.

[1] A COA indicates that a particular lot has been tested and found negative for E. coli O157:H7.  Products that do not carry COA’s are not subject to any rigorous testing for the presence of E. coli O157:H7 because they are not intended for use in a grinding operation.