By JIM RUTLEDGE
D.C. Correspondent WASHINGTON, D.C. — An audit by the federal government’s top health agency watchdog has found U.S. Food and Drug Administration (FDA) inspectors failed to enforce serious violations in one of every five food safety inspections at processing facilities – the source of thousands of cases of contaminated food that annually sends tens of thousands of consumers to hospitals. The audit by the Office of the Inspector General for the Health and Human Services Department (HHS) found that of 1,535 major food-safety violations between 2011-15, the FDA took action on 78 percent of the cases, but ignored more than 300 serious complaints. The Centers for Disease Control and Prevention (CDC) and the HHS say last year one in six Americans was hospitalized with foodborne illnesses, the most for salmonella that inspectors traced to chicken products. Of 130,000 hospitalized overall, 3,000 people later died. FDA inspectors are responsible for inspecting facilities that produce and handle food to ensure safety and that companies are in compliance with regulations. The FDA’s mission was expanded following the implementation of the 2011 Food Safety Modernization Act, which mandated the agency carry out routine inspections of all domestic food processors. Between 2011-15, the FDA identified 21,086 facilities as high-risk operations. In 2015, 16,135 facilities were visited, compared to 86,032 plants subject to inspection, the audit showed. Restaurants, cafeterias and grocery stories are subject to food safety inspections by state and county health departments. “We found a number of weaknesses in the way that FDA is protecting the food supply,” said Meridith Seife in an interview with National Public Radio. For instance, she said, the FDA often relies on the facilities to voluntarily correct violations, which is often ineffective, and there is no follow-up on site inspections. Jodi Nudelman, the regional inspector general for HHS and the author of the audit, said, “These inspections are essential. The follow-up is essential. That’s how you ensure a safe food supply, and we found a number of really serious problems.” The 35-page report concluded that FDA inspectors “consistently failed to conduct timely follow-up inspections to ensure the facilities corrected significant inspection violations.” In 17 percent of the cases, the HHS said the FDA did not conduct follow-up inspections at all, even though they found significant violations and took no enforcement action. In conclusion, the auditors recommended the FDA must: •Improve how it handles attempted inspections to ensure better use of the agency’s resources •Take immediate and appropriate action against all facilities with significant inspection violations •Improve the timeliness of its inspection actions so that facilities do not continue to operate under harmful conditions •Conduct timely follow-up inspections to ensure that significant inspection violations are corrected Despite recommendations to step up inspections, the White House has proposed an $83.8 million reduction in the FDA’s food safety program, with the bulk of the funding resulting in a number of food inspectors losing their jobs. The overall 2018 FDA budget is $5.1 billion, with more than 17,400 workers including 8,500 inspectors. The FDA says the reduced staffing in the food safety program will come through attrition with no direct layoffs. Many members of Congress say they are opposed to any FDA staff cutbacks, with the 2018 budget approval still more than a month away. With regards to the HHS audit, officials said the FDA has “concurred with all four recommendations.” To view the 35-page audit, visit https://oig.hhs.gov/oei/reports/oei-02-14-00420.pdf or to obtain a copy email Public.Affairs@oig.hhs.gov |
