If you like spinach you might not want to read a new report from the House Committee on Oversight and Government Reform called “FDA and Fresh Spinach Safety.”
After a deadly outbreak of E. coli 0157:H7 in September 2006, the committee examined the Food and Drug Administration’s efforts to protect the safety of packaged fresh spinach. What they found wasn’t pretty.
From the report:
Packaged fresh spinach facilities were inspected only once every 2.4 years, less than half of FDA’s stated goals. Frequent inspections are the cornerstone to the current safeguards for fresh produce and adequate resources are required for frequent inspections. FDA’s performance goals state that 95% of high risk facilities like packaged fresh spinach facilities should be inspected at least once yearly. Over a seven-year period, FDA provided 199 inspection reports for 67 packaged fresh spinach facilities. This translates to an inspection rate of about one inspection of each facility every 2.4 years, less than half of FDA’s stated goal.
FDA observed objectionable conditions during 47% of the packaged fresh spinach facility inspections. Of the 199 inspections reviewed, 93 documented “objectionable conditions,” the most common of which involved plant sanitation, plant construction, and worker sanitation. For example, more than 60% of the inspections with “objectionable conditions” revealed problems related to facility sanitation, such as inadequate restroom cleanliness or accumulations of litter.
Despite observing objectionable conditions in packaged fresh spinach facilities, FDA took no meaningful enforcement action. FDA did not refer any of these inspections with objectionable conditions for further action by its own enforcement authorities. In one case, FDA did refer one inspection to the state for further action. FDA did not issue warning letters or pursue more aggressive steps such as seizures or injunctions.
FDA overlooked repeated violations. In 38 cases, FDA observed repeated violations by packaged fresh spinach facilities but did nothing to force correction. Instead of taking enforcement action, FDA continued to request voluntary compliance after recording violations at each inspection. 14 of these repeat requests for voluntary compliance were for precisely the same violations.
The report also revealed that the FDA does no testing of fields where spinach is grown, despite the fact that this is where the contamination likely comes from.
The California Department of Health Services and the FDA performed a joint investigation into the causes of the 2006 spinach outbreak and found that the outbreak probably did not originate in the facilities that are inspected by FDA. Instead, the problem began outside the plants and most likely was due to contamination of the water outside of the plant by cattle feces, pig feces, or river water. FDA does not routinely inspect the fields except in outbreak investigations. In fact, none of the 199 Establishment Inspection Reports reviewed by Committee staff indicated that any observations of field conditions had taken place.
The report concluded that the FDA is essentially useless: It appears that FDA is inspecting high-risk facilities infrequently, failing to take vigorous enforcement action when it does inspect and identify violations, and not even inspecting the most probable sources of many outbreaks.