Counsel to Counsel - January 2008 - (Page 12) in the spotlight Responding Rapidly as Inspections and Recalls Rise By John M. Toth Justin Sullivan/Getty Images News/Getty Images F rom spinach and fresh ginger to meat and dairy products, highly publicized food product recalls have created a public perception of an unsafe food supply and inadequate regulation. The U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) have responded with more frequent and aggressive inspections of food producers. James F . Neale, a McGuireWoods LLP litigation partner who focuses on product and consumer issues, urges industry clients to develop response strategies that not only preserve positive relations with industry regulators, but also provide a more accurate view of the efforts made by producers to provide safe products. Neale says the best way for food companies to meet these goals begins with “an integrated inspection and recall response plan that will support regulatory integrity, provide timely, accurate information and meet the scrutiny of plaintiffs’ lawyers should litigation ensue.” Accommodating Guests “It helps if food companies have facilityspecific as well as product-specific inspection response protocols,” Neale advises, “because producers often deal simultaneously with multiple inspectors, and those inspectors expect a quick and complete response in today’s sensitive atmosphere.” Inspectors from the USDA are frequent visitors—often with resident inspectors stationed in larger plants. FDA inspectors generally make less frequent but sometimes more intense inspections, often without notice. The FDA also has the Office of Criminal Investigation (OCI), whose almost 200 special agents can present search warrants for a probable cause inspection. An effective response protocol, regardless of the inspecting body—or how familiar the inspectors may be with your company and its facilities—often starts with a designated inspection coordinator and a trained backup. “The strength of your response frequently depends on the knowledge and training of your coordinators,” Neale says. While inspectors are not generally authorized to take photos or request trade secrets, they can ask for additional information, and inspection coordinators must be able to respond promptly. “Written company responses within two weeks used to be acceptable, but no longer,” Neale says. “The USDA and FDA feel public pressure for ‘action’ as much as the companies do, but a cooperative approach generally produces the best results for everyone—the public included.” 12 LexisNexis® Martindale-Hubbell®
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