The U.S. Food and Drug Administration (FDA) has published its final rules under the Food Safety Modernisation Act (FSMA).
Signed into law by U.S. President Obama in January 2015, the FSMA strengthens the food safety system in the U.S. by employing a proactive approach intended to prevent food safety problems from occurring, rather than relying on reactive strategies such as product recalls. The law also gives the FDA expanded enforcement authority over both domestically-produced and imported foods.
The final rules require that food facilities covered under the scope of the FSMA must establish and implement a food safety system that includes a hazard analysis, risk-based preventative controls, and a written food safety plan. The final rules also clarifies the definition of a “farm", establishes more flexible requirements for supply-chain programmes, and updates current good manufacturing practices.
Compliance with the provisions of the new rules begins as early as September 2016 for most businesses. Small businesses (defined as those companies with fewer than 500 full-time employees) will have two years to achieve compliance, while very small businesses (defined as those with less than $1 million per year in annual sales) will have three years.
Additional details regarding the FDA’s GMP and prevention control rules are available here.