As part of its oversight of the safety of U.S. food products, the U.S. Food and Drug Administration (FDA) inspects imported foods at the border or port of entry for evidence of adulteration or misbranding. FDA has limited resources, and physically inspects about 1 percent of the approximately 60 million tons of food under its regulatory authority imported into the United States each year—products ranging from Spanish clementines to ground pepper and rice from India. FDA inspectors target certain firms and types of products that are prone to greater risks. When an inspector identifies an adulteration or misbranding violation, the shipment is subject to refusal into the United States.
ERS researchers analyzed the records of FDA refusals over 2005-13 to assess patterns in import refusals by product category, violation type, and exporting country and compared results with an earlier study analyzing similar data over 1998-2004. In both time periods, the top three products in terms of refusals were fishery/seafood products, vegetables/vegetable products, and fruit/fruit products. The countries with the most food shipments refused by FDA—Mexico, India, and China—have distinct sets of product categories that reflect the quantities and types of products they export to the United States.
FDA Uses a Risk-Based Inspection Protocol
FDA does not have the resources to examine every shipment of food entering the United States. Thus, FDA inspectors must prioritize and target certain exporting countries, producers, importers, commodities, or products it expects to pose greater risk to human health or to more likely be in violation of U.S. regulations. FDA uses a set of risk-based criteria to determine which shipments should be inspected. The nonrandom nature of FDA sampling means that researchers cannot draw inferences about the relative safety of food produced in various countries or the relative risk of certain food products. Instead, FDA import refusals reveal recurring patterns of import violations in food products that have repeatedly attracted the attention of FDA inspectors.
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