Health and Human Services report highlights FDA neglect of food safety

In spite of an increase in the number of commercial food processors and a rise in foodborne illness outbreaks – one of the largest a result of Central Valley spinach producers – the number of food facilities the U.S. Food and Drug Administration has inspected has declined significantly over the last decade. The number of violations identified by inspectors has also fallen.

All of this according to a report issued this week by the U.S. Department of Health and Human Services inspector general’s office. What is more troubling, the report states that “when violations were identified, FDA did not routinely take swift and effective action to ensure that these violations were remedied.”

Upon inspecting a food manufacturing facility, the FDA classifies each facility in one of three ways: official action indicated (OAI), voluntary action indicated (VAI), or no action indicated (NAI). The agency can change the initial classification under certain circumstances. Instances which require an OAI grading are subject to enforcement action through legal proceedings if the problem isn’t corrected voluntarily.

Here are some highlights directly from the report:

On average, FDA inspects less than a quarter of food facilities each year, and the number of facilities inspected has declined over time.

Fifty-six percent of food facilities have gone 5 or more years without an FDA inspection.

The number of facilities that received OAI classifications has declined over time.



FDA took regulatory action against 46 percent of the facilities with initial OAI classifications; for the remainder, FDA either lowered the classification or took no regulatory action.

For 36 percent of the facilities with OAI classifications in FY 2007, FDA took no additional steps to ensure that the violations were corrected.

Based on these findings, the report recommends increased frequency of food facility inspections, bestowing statutory authority upon the FDA to impose civil penalties on those who do not voluntarily comply with regulations, and granting the FDA the legal authority to access all facility records during the inspection process.

“Taken together, the findings demonstrate that more needs to be done to protect public health and to ensure that FDA has the necessary tools to prevent outbreaks of foodborne illness” the report says.

The FDA has reported to the Inspector General’s Office that it does support the proposed legislative changes. But, granting more authority to a federal agency that routinely fails to use its existing power to protect the health and welfare of Californians is a topic for further discussion.