1. INTRODUCTION

The U.S. FDA Food Safety Modernization Act (FSMA), enacted in January 2011, fundamentally shifts the focus of food safety in the United States from responding to food safety incidents after they occur to preventing them from happening. FSMA applies to the safe production of all foods sold in the U.S., including agricultural products, raw materials, processed foods, food additives and GRAS substances, and includes requirements for appropriate Quality Systems, Preventive Controls and Good Manufacturing Practices (GMPs) during product manufacture, transport and storage. These requirements appear in the U.S. Code of Federal Regulations at Title 21, Part 117 (21 CFR Part 117) and remain consistent with Current Good Manufacturing Practice (CGMP) requirements followed by industry that existed prior to FSMA.¹