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US: Understanding FDA's new FSMA rule for produce farms

The Food Safety Modernization Act (FSMA), signed into law in January 2011, authorizes the U.S. Food and Drug Administration (FDA) to take a preventive approach to food safety. This new approach includes the authority to establish first-time food safety requirements for farms producing fruits and vegetables, among other requirements for participants across the food supply chain.

Earlier this year, FDA finalized the Preventive Controls Rule, which governs food processing operations, which can include farms depending on the degree of value-added processing they are doing. Now, FDA has finalized the Produce Safety Rule, which sets food safety standards for farms to follow in an effort to minimize the risks of microbiological contamination that may occur during the growing, harvesting, packing, and holding fresh produce. These two rules are among seven major rules that span across the supply chain, from farms to transportation to processing to imports.

Not all farms will be subject to the new Produce Rule; some will be exempt from all requirements, some may be eligible for modified requirements. To understand whether the rules apply to a particular operation, it is important to start with some key definitions.

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