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practicalwinerylibrary.com Access Practical Winery & Vineyard article archives online. TECHNICAL RESOURCE FOR GROWERS & WINERIES 58 Deductibility of soil amendments By L. Gregory Scott and David G. Pardes 60 Temecula Valley: A side of food with your wine? By Elisabeth Deffner 64 New York wineries: Best & Worst business decisions By David Furer s winery safety food safety modernization act F a Inspections, compliance strategies o f and opportunities for comment S o e BY Rebecca Anderson Smith, Downey Brand LLP, Sacramento, Calif. W ineries have been subject to oversight by the Food and Drug Administration (FDA) for years, but because these operations pose a relatively low risk of food-safety hazards, the heavily burdened agency's focus has rarely drifted to wineries and vineyards. This paradigm has begun to shift, due in part to the enactment of the federal Food Safety Modernization Act (FSMA) in January 2011. The FDA is now seeking comment from members of the public regarding the reach, breadth and science relating to the potential impact of the FSMA on wineries. Several key proposed rules are out for public comment until November 2013, and more regulations (with additional opportunities to comment) are expected in the next two years. The resulting developments in food-safety regulation will have important implications for the wine sector. The FSMA requires the FDA to inspect every registered food facility in the United States, including wineries, by 2018. Alongside this inspection directive, the FSMA directs the FDA to implement certain key preventative measures to ensure food safety in the U.S., including developing a food-tracing program and setting certain minimum foodsafety protocols for high-risk foods. The FSMA gives the agency considerable authority to develop and implement new regulations in pursuit of those food-safety goals. d t y The FSMA directs the FDA to inspect every registered facility in the United States, including wineries, by 2018. As it attempts to meet the ambitious food-safety goals of the FSMA, the FDA is seeking science-based feedback and guidance from the wine sector regarding the way that this sector functions, and what food-safety concerns (if any) are actually at issue during the winemaking process. FDA oversight of wineries pre-FSMA The Federal Food, Drug, and Cosmetic Act defines "food" broadly, to include nearly anything (including wine) meant for human or animal consumption, and this broad definition brings wine under the FDA regulatory authority. Until recent years, any oversight that the FDA did exercise for wineries was cursory, 52 p r acti c al w i ne ry & v i n e yard S EPTE MBER 20 13 F O O D A F E T Y and winery oversight was left largely to other agencies. During the past 10 years, however, that pattern has begun to shift. After the passage of the federal Bioterrorism Act in 2002, any facility engaged in manufacturing, processing, packing or holding food for consumption in the U.S. was required to register with the FDA. Wineries, custom-crush operations and even mobile bottling operations all fell within the scope of this federal requirement and have been required to register with the FDA since 2003. The Bioterrorism Act also gave the FDA authority to impose record-keeping requirements on registered facilities and to enter and inspect those facilities under its federal food-safety authority, though winery inspections have long been the exception rather than the rule. Even without the FDA oversight, wineries have long been subject to a complicated regulatory structure, with multiple agencies exercising oversight over aspects of the wine operation. For example, the same wineries that submit FDA registration under the federal Bioterrorism Act are also required to register or obtain permits from the TTB. State and local regulations, including both state law and county health ordinances, can raise additional complications (though these issues are out of the scope of the current article).