FDA Announces Pilot Program for Two-Tier Preventive Controls for Human Food Inspections under FSMA

The U.S. Food and Drug Administration (FDA) recently announced that it will engage in a pilot program to evaluate the benefits of two-tier inspections for some aspects of the Preventive Controls for Human Food (PCHF) rule under the FDA Food Safety Modernization Act (FSMA). Through a Notice to Industry, FDA is inviting food companies with multiple facilities that implement centrally developed supply-chain programs and recall plans to apply to participate in two-tier inspections. FDA plans to limit initial participation in the program to five businesses. FDA will consider the results of the two-tier inspections pilot to determine the feasibility of employing the two-tier approach to inspections on a broader scale.