Report cites weaknesses in FDA spinach inspection

Mar 13, 2008 (CIDRAP News) – An investigation by a congressional oversight committee into the US Food and Drug Administration's (FDA's) inspection of fresh spinach revealed lax enforcement at facilities that had violations.

The 10-page report, released yesterday, was requested by the US House of Representatives Committee on Oversight and Government Reform in the wake of a 2006 Escherichia coli O157:H7 outbreak linked to fresh spinach. The outbreak was traced to contaminated spinach from California's Salinas Valley and involved 204 cases and 3 deaths in 26 states and one Canadian province.

According to the report, the findings are based on the FDA's inspection records of all firms that produced packaged fresh spinach from 2001 to 2007. One of the key findings was that fresh spinach facilities were inspected only once every 2.4 years, less than half of the FDA's goals. The report states that the FDA's goal is to inspect 95% of high-risk facilities, such as those that produce packaged spinach, at least once a year. However, for the investigation period, the FDA provided 199 inspection reports for 67 facilities.

The report said the FDA observed "objectionable conditions" during 47% (93) of the 199 inspections. The most common ones involved plant sanitation, plant construction, and worker sanitation. For example, more than 60% of the inspections that recorded objectionable conditions documented facility sanitation problems, including inadequate restroom cleanliness or litter accumulation. Other problems included water condensation inside some of the plants that could contaminate spinach with waterborne pathogens.

When FDA investigators found objectionable conditions, investigators found they took no "meaningful" enforcement action and overlooked repeat violations, even at multiple facilities operated by Natural Selection Foods, the firm that was linked to the 2006 E coli O157:H7 outbreak.

FDA inspectors were more likely to request voluntary compliance of violators, rather than take enforcement actions such as warning letters, seizures, or injunctions.

Some of the findings suggest that in some instances the FDA lacks the authority to do its job. On eight occasions, facilities barred FDA inspections from fully reviewing their food safety practices. Current laws don't empower the FDA to compel firms to produce records. "On one occasion, inspectors were denied access to written records by the facility that was the site of the 2006 outbreak," the authors wrote.

The scope of FDA inspections appears to be too narrow to identify the sources of an E coli outbreak, the investigators found. For example, in the 2006 spinach outbreak California and FDA officials determined that the outbreak was probably caused by contamination, such as cattle or wild-pig feces or tainted water, in spinach-growing areas.

The FDA does not routinely inspect fields except in outbreak investigations, the report stated, adding that none of the 199 inspection reports mentioned field condition observations.

"The inspection reports provided to the committee raise serious questions about the ability of the FDA to protect the safety of fresh spinach and other fresh produce," the investigators wrote.

Inadequate funding and resources for the FDA's food safety activities may be hampering the agency's ability to protect the safety of fresh spinach, the report says.

In December 2007, the FDA's science board, an independent advisory committee, issued a report that the FDA's ability to conduct routine inspections and perform its enforcement and regulatory duties has "severely eroded" and couldn't be fixed with its current resources.

FDA spokeswoman Kimberly Rawlings said that the agency is seeking legislative authority to launch a food protection plan that targets some produce and foods that have been connected to recent outbreaks, according to a Washington Post story today.

Despite the recent food contamination episodes, the United States still has one of the safest food supplies in the world, including its fresh produce, she told the Post.

See also:

Mar 12 US House oversight committee report on fresh spinach safety
http://oversight.house.gov/documents/20080312103036.pdf

Dec 5, 2007, CIDRAP News story "Report says stingy funding has put FDA in crisis"

Mar 23, 2007, CIDRAP News story "FDA releases final report on spinach E coli outbreak"