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March 19, 2008

Report finds FDA lax in spinach inspections

933500_spinach2 Popeye would probably think twice about eating his favorite food if he got a chance to read a report recently released by the House Committee on Oversight and Government Reform called “FDA and Fresh Spinach Safety.”

The findings paint a most unappetizing picture of food safety and once again underscore the need to give the Food and Drug Administration more resources to oversee the safety of the nation’s food supply.

The committee’s investigation was prompted by the September 2006 outbreak of E. coli 0157:H7 that caused hundreds of reported injuries and several deaths—an outbreak that was ultimately traced to packaged fresh spinach.

Among the findings:

  • Packaged fresh spinach facilities were inspected only once every 2.4 years, less than half of the FDA’s stated once-a-year goal.
  • FDA observed objectionable conditions during 47 percent of the packaged fresh spinach facility inspections; the most common involved plant sanitation, plant construction and worker sanitation. For example, more than 60 percent 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. Although the FDA did refer one inspection to the state for further action, it did not issue warning letters or pursue more aggressive steps such as seizures or injunctions.
  • In 38 cases, FDA observed repeated violations by packaged fresh spinach facilities but did nothing to force correction.
  • FDA found repeated problems at multiple facilities operated by the firm implicated in the 2006 E. coli outbreak but took no enforcement actions. The records show that in the years prior to the outbreak, FDA conducted multiple inspections of several packaged fresh spinach facilities operated by Natural Selection Food and repeatedly found problematic conditions at a number of their facilities. According to the inspection records, however, FDA at no time required the firm to correct these conditions at any of its facilities, even after laboratory tests indicated the presence of microbial contamination at the exact site later implicated in the 2006 outbreak.
  • In eight cases, packaged fresh spinach facilities denied FDA inspectors access to records or other relevant material. Under current law, FDA lacks the authority to compel production of firm records. On one occasion, inspectors were denied access to written records by the facility that was the site of the 2006 outbreak.

What’s more, even if the FDA had been conscientiously inspecting these plants, the investigation found that the scope of the agency’s inspections “appears too narrow to capture the sources of an E. coli outbreak."  After all, the source of the 2006 spinach-related outbreak probably did not originate in the facilities that are inspected by FDA but rather outside the plants and most likely was due to contamination of the water by cattle feces, pig feces, or river water.

Yet FDA does not routinely inspect the fields except in outbreak investigations: “Laboratory sampling can detect some microbial contaminations, but cannot prevent many outbreaks. The outdated statutory sanitation standard severely limits the scope of FDA’s ability to adequately prevent many outbreaks.”

Samantha Cabaluna, spokeswoman for Natural Selection Foods, said in an e-mail that her company does “agree with the committee’s findings that there is a need for strong federal oversight of food safety and a better-funded FDA. We have, in fact, been working with several coalitions to support stronger food safety standards."

The FDA, in a statement, said the agency is working on a food-protection bill to deal with high-risk food, including produce, and urges Congress to enact its proposed legislation by Memorial Day. "Despite recent concerns," the statement said, "the food supply in the U.S. continues to be one of the safest in the world and this includes fresh produce."

Given the number of recalls in recent years, consumers may beg to differ. As the congressional report shows, the FDA is very clearly an agency in need of immediate help. Consumers Union expects congress to address food safety in the coming months. Faith in our food system would be a welcome change for all of us.

A funny take on a serious issue
In case you missed it, editorial cartoonist Tom Toles, featured a funny face-off between Popeye and the FDA in a strip earlier this week.

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