P2-65 Poor GMPs Lead to a Second Occurrence of Staphylococcal Food Poisoning

Tuesday, July 24, 2012
Exhibit Hall (Rhode Island Convention Center)
Jennifer Hait, U.S. Food and Drug Administration, College Park, MD
Sandra Tallent, U.S. Food and Drug Administration, College Park, MD
David Melka, U.S. Food and Drug Administration, College Park, MD
Christine Keys, U.S. Food and Drug Administration, College Park, MD
Reginald Bennett, U.S. Food and Drug Administration, College Park, MD
Introduction: Over 100 individuals were sickened after ingesting an assortment of desserts linked to four staphylococcal food poisoning outbreaks leading investigators to products manufactured by an Illinois bakery. Less than a year later the same bakery was implicated in a second staphylococcal food poisoning outbreak involving the firm’s Black and White Chiffon Mousse Cake served at a birthday party with 16 complaints of illness. This study examines association and pathogenic potential of the isolates recovered from the environmental and product samples obtained during multiple inspections of this firm.

Purpose: Investigation of a firm implicated in reoccurring incidences of staphylococcal food poisoning episodes.

Methods: S. aureus isolates were evaluated using either commercially available serological kits or a multiplex PCR method for the identification of staphylococcal enterotoxins SEA-SEE, SEG-SEI, SE-like SElJ-SElU or their respective genes and for Panton-Valentine leukocidin (PVL) cytotoxin. Antimicrobial susceptibility testing was performed using the VITEK 2 AST-CP67 Gram Positive Susceptibility Card, an in vitro method used in clinical laboratories for antimicrobial testing. PFGE subtyping method was performed for the 85 S. aureus isolates digested with the primary enzyme SmaI.

Results: FDA’s investigative team visited the bakery several times and identified substantial deviations from the current Good Manufacturing Practice Regulations monitored by their Code of Federal Regulations 21 CFR. A concentrated whipped topping ingredient and 12% of the environmental samples revealed the existence of enterotoxigenic S. aureus isolates capable of producing diverse combinations of toxins. Additionally, antimicrobial susceptibility testing found that all S. aureus isolates were resistant to one or more agent(s). PFGE characterization identified thirteen pattern types from the bakery’s environment and the raw ingredient sample.

Significance: The significant observations resulting from this investigation demonstrates the prevalence and diversity of antimicrobial resistant strains of S. aureus carrying of both classical SE’s and genes for non-classical SE and SE-like enterotoxins found in the environment.