Microbiological Safety Validation of Food Processes

The Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011 by President Obama. It represents the largest expansion of food safety requirements and FDA food safety authorities since the enactment of the original Food Drug & Cosmetic Act in 1938. It adds Section 418 to the US FD&C Act, requiring facilities to perform a hazard analysis and implement a preventive controls plan. The intent of the law is to protect foods from exposure to known or reasonably foreseeable biological, chemical (including allergens and economically motivated adulteration), physical and/or radiological hazards. In total, FSMA requires the FDA to produce approximately 50 new regulations and guidance documents addressing federal food safety requirements.