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Understanding FSMA's Preventive Contols Rule: A Guide for Grain Businesses

This guide was developed by the Artisan Grain Collaborative and Vermont Law School's Center for Agriculture and Food Systems; its purpose is to empower grain farmers, processors, and food manufacturers to understand and comply with federal food safety laws.

The Food Safety Modernization Act (FSMA) became law in 2011 and has been the most sweeping overhaul of U.S. federal food safety laws in seven decades. A key component is the Preventive Controls for Human Food Rule (PCR), which requires businesses conducting processing and handling to evaluate possible food safety hazards, take action to prevent or reduce those hazards, and create monitoring systems to ensure the steps they take are effective. However, it can be challenging for small - and medium-sized farms, which are often multi-faceted businesses that store, process, distribute, and market foods to determine if and how the PCR is applied. The guide includes:

  • background information on the evolution of regional grainsheds and key terminology;
  • a flowchart to help grain farms and businesses determine what type of entity category they fall into according to regulatory language;
  • information on specific farms, processing facilities, retail food establishments, and restaurants;
  • information about how the Preventive Controls for Human Food Rule applies to various entities that process grains; and
  • a discussion of how particular activities fit within the rule and helps producers understand if and how their activities make them subject to it.