Key components of the Food Safety Modernization Act (FSMA) are the obligations placed upon owners and operators of human and animal food facilities to conduct hazard analyses and implement preventive controls that address the identified hazards. These obligations, along with other FSMA requirements, are designed to shift the focus of U.S. food safety away from incident response and toward prevention. After years of discussion, public comment and even litigation, FDA finalized rules on hazard analysis and preventive controls for human and animal food on Sept. 10.
The Preventive Controls Rules, as they are generally known, apply to “covered facilities”—those facilities that manufacture, process, pack or hold food. In other words, if the facility is required to register with FDA, the preventive controls rules apply. Excluded, however, are farms, which are defined as operations devoted to growing and harvesting crops, raising animals or any combination. Certain operations conducted on farms, such as packing and storing operations, will not eliminate the exemption, although exempt farming operations may be covered by the Product Safety Rule.