For more than four years, food industry stakeholders have been eagerly awaiting publication of the final versions of the “seven foundational rules” mandated by FDA Food Safety Modernization Act (FSMA). This month, the Food and Drug Administration (FDA) issued the two final rules requiring facilities to identify potential hazards and implement controls for human food and animal food.

In the simplest terms, the final rule for human food requires firms to identify significant food safety risks, implement controls to mitigate the risks, monitor and verify the effectiveness of the processes, manage supply chain risks, and document activities. Continue Reading

Under the Food Safety Modernization Act (FSMA), food manufacturers are charged with employing processes that mitigate risks and aid in the delivery of safe and stable products. Manufacturers employ a wide range of thermal processes to inactivate spoilage microorganisms and pathogens that can affect product shelf-life. Verifying the effectiveness of these processes through well-designed and executed validation studies is essential in today’s regulatory environment.  Continue Reading

One of the centerpieces of The Food Safety Modernization Act (FSMA) focuses on preventative sanitation control, requiring manufacturers to implement a food safety plan to control hazards that can potentially introduce microorganisms into the finished product. Due to the heightened emphasis on prevention, an effective environmental monitoring system (EMS) provides manufacturers with critical data and information on the microbiological condition of their plants. When these systems are not correctly implemented and maintained, plants are at a greater risk of encountering safety issues that can result in increased liability exposure. Continue Reading