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Committee on Oversight and Government Reform Report on the FDA and Fresh Spinach Safety

In 2006, an E. coli O157:H7 outbreak was linked to packaged fresh spinach.  205 people were had laboratory-confirmed cases of the outbreak strain of E. coli O157:H7.1 According to the FDA, this was the 20th major outbreak of E. coli O157:H7 in fresh lettuce or spinach since 1995.2

This month, the United States House of Representatives Committee on Oversight and Government Reform issued a report on their investigation into the Food and Drug Administration’s efforts to protect the safety of packaged fresh spinach entitled, “FDA and Fresh Spinach Safety.”  As part of the investigation, the committee requested and received inspection records for all FDA inspections of firms producing packaged fresh spinach from 2001 to 2007. The committee’s investigation of the FDA inspection records revealed that during this time period the FDA did not providing adequate oversight of packaged spinach plants and did not take enforcement actions when FDA inspectors observed and reported “objectionable conditions” at the plants.  Instead the FDA requested voluntary compliance after recording violations, and there were numerous violations.

Below is the committee’s summary of its findings followed by our commentary.

  • Packaged fresh spinach facilities were inspected only once every 2.4 years, less than half of FDA’s stated goals. FDA’s performance goals state that 95% of high risk facilities like packaged fresh spinach facilities should be inspected at least once yearly.
  • FDA observed objectionable conditions during 47% of the packaged fresh spinach facility inspections. The most common problem observed related to basic plant cleanliness: more than 60% of the inspections reporting “objectionable conditions” revealed problems related to facility sanitation, such as inadequate restroom cleanliness or accumulations of litter. The next most common problem identified was plant construction, cited in more than half of the violations. Observations in this area included findings that condensation had accumulated inside the plant, threatening to contaminate the food with water-borne microorganisms, and that plant design allowed for rodent infiltration, which might introduce filth or otherwise contaminate the food. The third major concern was worker sanitation, including issues such as uncovered hair, jewelry, or clothing, and poor hygiene practices. Worker sanitation concerns were raised in more than one tenth of the violations.
  • 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.  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.
  • 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 LLC and repeatedly found problematic conditions at a number of these 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. In eight instances, facilities prevented FDA inspectors from conducting a full review of the food safety practices. 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.
  • The scope of the FDA inspections appears too narrow to capture the sources of an E. coli outbreak. 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. 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.

The committee report states, “The inspection reports provided to the Committee raise serious questions about the ability of FDA to protect the safety of fresh spinach and other fresh produce. 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.”

We would go further and suggest that these findings prove conclusively that FDA is not protecting the safety of fresh spinach.  This is due primarily to a lack of will to enforce the laws that are in place to protect consumers of fresh produce.  No amount of funding and regulatory authority is going to change that. 

There needs to be a food safety regulatory agency that is responsible for the safety of all food products sold in the United States.  This new agency has to have the authority to take whatever measures are necessary to protect our food system from farm to fork.  This agency also needs to be protected from political influences so that a change of administration can't render the new agency ineffectual.

The E. coli O157:H7 outbreak linked to fresh, packaged spinach has led to a substantial amount of rhetoric and volumes of reports, but no significant changes have occurred that would prevent this tragedy from being repeated.  We can only hope this report from the Committee on Oversight and Government Reform, “FDA and Fresh Spinach Safety,” will lead to meaningful change.

References:

1. United States House of Representatives Committee on Oversight and Government Reform, FDA and Fresh Spinach Safety (March 2008).
2. California Department of Health Services and the U.S. Food and Drug Administration, Investigation of an Escherichia coli O157:H7 Outbreak Associated with Dole Pre-Packaged Spinach (Mar. 27, 2007).
3. FDA, Letter to California Firms that Grow, Pack, Process, or Ship Fresh and Fresh-cut Lettuce (Nov. 4, 2005). According to this 2005 letter, 19 outbreaks of E. coli O157:H7 in lettuce or spinach occurred from 1995 to 2005. The outbreak in 2006, therefore, was the 20th outbreak since 1995.

Pritzker | Olsen, P.A., a leading food poisoning litigation law firm, has gained a national reputation, and lawyers at the firm have been interviewed by The New York Times, The Wall Street Journal, Lawyers USA and other publications.  In recognition of their achievements, Fred Pritzker, Elliot Olsen and Eric Hageman have been named "Super Lawyers" by a state legal magazine.  Fred Pritzker has been selected by other lawyers for inclusion in The Best Lawyers in America.  To contact the firm, please call toll-free at 1-888-377-8900 or submit the firm's online consultation form for review by an E. coli lawyer. 

 


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