Shutdown hobbles but does not close F.D.A.

by Jay Sjerven
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WASHINGTON — The shutdown of the federal government will severely restrict but not close down the U.S. Food and Drug Administration’s efforts to ensure the safety of the nation’s food supply.

Under the contingency plan prepared by the Department of Health and Human Services in the event of a government shutdown or interruption in federal funding, which was implemented today, 6,620 staff were to be furloughed, which amounted to 45% of the F.D.A. workforce that numbered 14,779 as of Oct. 1. The F.D.A. retained 8,180 employees, or 55% of its workforce. Those retained included personnel paid for by carryover funds (i.e. user fees) and about 1,000 “commissioner corps officers.”

Under the contingency plan, the F.D.A. indicated during a government shutdown it would continue limited activities related to its user fee-funded programs, including the activities of the Center for Tobacco Products. The F.D.A. also will continue select vital activities, including maintaining critical consumer protection to handle emergencies, high-risk recalls, civil and criminal investigations, import entry review and other critical public health issues.

But the F.D.A. will be unable to support the majority of its food safety activities such as routine establishment inspections, some compliance and enforcement activities, monitoring of imports, notification programs (eg. food contact substances, infant formula), and the majority of the laboratory research necessary to inform public health decision-making.

The 698 F.D.A. staff who will be “excepted” from the furloughs “for the protection of human life” include 578 staff to inspect regulated products and manufacturers, conduct sample analysis on products and review imports offered for entry into the United States. This number includes active investigators who will be needed to perform inspections, recall operations, emergency response, review import entries and make admissibly decision. The remaining staff would be conducting and overseeing adverse event reporting and lot release protocol reviews as well as providing support with surveillance, product incidents, compliance, recalls and emergencies.
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