Yesterday Congress Members Waxman and DeLauro released a report chastising both the FDA and industry for allowing over 20 E. coli outbreaks tied to leafy green vegetables. These failures the committee concluded lead to the 2006 Dole/Natural Selection Food’s/Mission Organics Spinach E. coli O157:H7 outbreak that sickened 205, killing 5. The report in part found:
• Packaged fresh spinach facilities were inspected only once every 2.4 years, less than half of FDA’s stated goals.
• FDA observed objectionable conditions during 47% of the packaged fresh spinach facility inspections.
• Despite observing objectionable conditions in packaged fresh spinach facilities, FDA took no meaningful enforcement action.
• FDA overlooked repeated violations
• FDA found repeated problems at multiple facilities operated by the firm implicated in the 2006 E. coli outbreak but took no enforcement actions.
• In eight cases, packaged fresh spinach facilities denied FDA inspectors access to records or other relevant material.
Interestingly, had the FDA done its job earlier and specifically followed up on the PowerPoint presentation done by the St. Croix Health District in 2005, the 2006 outbreak might not have ever happened.