U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg has expressed support for the Food Safety Enhancement Act of 2009, which seeks to increase the agency’s authority over U.S. and foreign food producers, including the power to issue mandatory recalls of tainted foods. “FDA needs new legal authorities to succeed in these roles and protect the public health,” she was quoted as saying before the U.S. House Committee on Commerce and Energy on June 3, 2009. “This legislation would provide those tools.”

A group of congressional Democrats in late May released a discussion draft of the Act, which would take effect in 18 months if passed. The legislation includes provisions that would (i) create an up-to-date registry of all food facilities serving American consumers, (ii) require such facilities to pay a $1,000 fee to generate resources to support FDA oversight of food safety, (iii) strengthen criminal penalties and establish civil monetary penalties for food facilities that failed to comply with safety requirements, (iv) require high-risk facilities to be inspected at least once every six to 18 months, low-risk facilities once every 18 months to three years, and warehouses that store food to be inspected at least once every three to four years, and (v) enhance FDA’s ability to trace the origin of tainted food in the event of an outbreak of foodborne illness.

Hamburg also endorsed the annual registration fee of $1,000 on food companies and facilities, asserting that the fees would “represent a burden on companies” but signify “an investment in a robust and effective food safety system.” According to Democratic lawmakers, the fees would generate an estimated $378 million for increasing plant oversight and other FDA activities. Hamburg, however, did not recommend a specific number of inspections, noting that the fees would “not be adequate to implement the portfolio of activities laid out in the plan.”

Republican representatives have cautioned that the bill could grow bureaucracy and place financial burdens on small businesses through mandatory fees and more stringent food-tracing systems. The food industry has reportedly accepted the necessity of some fees, but criticized the draft legislation for its sweeping implications. “We are not opposed to all fees,” stated Pamela Bailey, president and chief executive of the Grocery Manufacturers Association. “We are concerned that a broadly applied fee to finance basic FDA functions, including inspections and
enforcement, creates an inherent conflict of interest that would erode, rather than improve, consumer confidence in our food supplies.” See Product Liability Law 360 and The Wall Street Journal, June 3, 2009; Reuters, June 4, 2009.

About The Author

For decades, manufacturers, distributors and retailers at every link in the food chain have come to Shook, Hardy & Bacon to partner with a legal team that understands the issues they face in today's evolving food production industry. Shook attorneys work with some of the world's largest food, beverage and agribusiness companies to establish preventative measures, conduct internal audits, develop public relations strategies, and advance tort reform initiatives.

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