The U.S. Food and Drug Administration (FDA) has finalized the first two of seven major rules under the Food Safety Modernization Act (FSMA). The Agency announced the availability of the pre-publications versions of Current Good Manufacturing Practice [cGMP] and Hazard Analysis and Risk-Based Preventive Controls [HARPC] for Human Food and Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals on September 10, 2015. The official versions are scheduled for publication in the Federal Register on September 17.
The final rules are an important step in preventing food safety problems before they happen. The Preventive Controls rules will also hold imported food to the same safety standard as domestically produced food, and will develop a nationally integrated food safety system in partnership with state and local authorities, explained FDA in a press release about the final rules. Both rules mandate that food manufacturing/processing facilities have a written food safety plan that identifies and monitors hazards and sets forth protocols for addressing those hazards. The rules also establish a risk-based supply chain program for those raw materials and other ingredients that are identified a hazard requiring a supply-chain-applied control.
For the human food Preventive Controls rules compliance depends on the size of the business. Businesses other than "small" and "very small" ones, as those terms are defined in the final rules, need to be in compliance with the cGMP and HARPC requirements in one year by September 2016. Small businesses (companies that employ fewer than 500 full-time employees) and ver small businesses have two and three years, respectively, to meet the requirements. For the animal feed Preventive Controls rules compliance dates are staggered based on cGMP and HARPC requirements based on business size; for business other than small and very small, cGMP compliance is required in one year and HARPC compliance is required in two years. For both rules, there are also separate compliance dates for the supply chain program based on the size of the receiving facility and the identity of the supplier.
A summary of Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food can be found here, and one for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals can be found here.