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Marler Blog Providing Commentary on Food Poisoning Outbreaks & Litigation

Topps Settles E. coli O157:H7 Illnesses Stemming from 2007 Outbreak

After two days of mediation in New York City, we were able to resolve several cases. However, a number were left unresolved. As readers recall, on August 31, 2007 a consumer complaint was filed with the USDA after a Florida resident fell ill after consuming a hamburger patty produced by Topps Meat Company (“Topps”) on July 12, 2007. The resident 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. Additional illnesses continued to be reported.

Topps 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 Food Safety and Inspection Service (FSIS) conducted an inspection of Topps’s plant in Elizabeth, New Jersey.

The FSIS inspection of Topps’s 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). 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. 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.”

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’s HACCP plan, the plan ostensibly in place to ensure the safety of Topps’s 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:

[D]emonstrated 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. See Notice of Suspension.

Not surprisingly, FSIS suspended Topps’s 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 products with un-expired sell by dates. Ultimately, the Topps’s 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.