New FDA Report Illustrates How Spending Cuts Threaten Food Safety
by Katie Greenhaw, 6/21/2011
The U.S. Food and Drug Administration (FDA) released a report yesterday recognizing the challenges in regulating imported products. The report acknowledges that the agency does not have "the resources to adequately keep pace with the pressures of globalization."
In the report, entitled Pathway to Global Product Safety and Quality, the FDA unveils "a new strategy to meet the challenges posed by rapidly rising imports of FDA-regulated products and a complex global supply chain," the agency's news release said. This comes less than a week after the House passed an appropriations bill cutting funding for FDA and the U.S. Department of Agriculture (USDA). With no support from Democrats, H.R. 2112 passed by a vote of 217-203. The bill cuts $2.6 billion in discretionary programs for child nutrition, research, conservation, and rural development, compared with last year's levels. The administration expressed concern with the bill, stating that the funding level "will severely limit the FDA's ability to protect the public's health" and assure the safety of food and medical products.
In addition to the funding and staff constraints on the agency, the report notes that "FDA has expanded its capabilities and regulatory authority" in response to globalization. The Food Safety Modernization Act (FSMA) of 2011 grants FDA the authority to refuse admission to imported food if the source refuses inspection and requires importers to perform verifications to ensure the food is safe, among other things. But the question remains – how will the agency fulfill its duty to ensure that imported foods (an estimated 60 percent of fresh fruits and vegetables and 80 percent of seafood consumed in the U.S. come from outside the country) are safe for the public without sufficient resources?
FDA's report refers to a 2008 recommendation by the Government Accountability Office (GAO) that the agency increase inspections of foreign drug establishments and improve information it receives to manage overseas inspections. "But at current rates," the report says, "it would take an estimated nine years for FDA to inspect every high-priority pharmaceutical facility just once." Similarly, FDA will be unable to conduct the food inspections mandated under the FSMA "without a substantial increase in resources or a complete overhaul in the way it operates." FDA's "mission will become ever more difficult to fulfill given the breadth and complexity of industries that it regulates during a time of constrained federal resources," the report concludes.