GFSI and FSMA: Will One Satisfy the Other?1
In this column, Stier discusses the final U.S. Food and Drug Administration (FDA) preventive controls regulation, “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food,” and how well following Global Food Safety Initiative (GFSI) approved audit schemes may prepare food processors to meet the new regulations. Since the passage of the Food Safety Modernization Act (FSMA) in 2010, there has been speculation concerning what the food industry will need to do to comply. Many food processors worldwide have adopted one of four GFSI-approved food safety schemes (FSSC 22000, BRC, SQF, and IFS). The question is, will adoption of one of these audit schemes satisfy the requirements of the FDA preventive controls regulation? The answer is, if a food processor has implemented and maintained a food safety management system and met the requirements of a GFSI-approved audit scheme or ISO 22000, the company should fulfill most of the requirements of the final FSMA preventive controls regulations. Several questions remain, however, since no one knows exactly how FDA investigators will interpret the final regulations. Will guidance be treated as guidance or something else? To prepare, food processors should look for audit firms and certifying bodies that are known to conduct rugged audits.