On September 26^th, the U.S. Food and Drug Administration (FDA) announced the availability of two new chapters to the Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food, designed to help food facilities comply with the preventive controls for human food rule mandated by the FDA Food Safety Modernization Act.  Chapter 11—Food Allergen Program and Chapter 16—Acidified Foods—are among the chapters that have been added since the draft guidance was first issued in 2016.  Below is more information about Chapter 11.

Chapter 11—Food Allergen Program—explains how to establish and implement a food allergen program that ensures protection of food from major food allergen cross-contact and that the finished food is properly labeled with respect to the major food allergens. The chapter provides many examples of ways to significantly minimize or prevent allergen cross-contact and undeclared allergens using current good manufacturing practices (CGMPs) and preventive controls. It also discusses circumstances in which, despite adherence to appropriate CGMPs and preventive controls, allergen presence due to cross-contact cannot be completely avoided and options the firm can consider, including the voluntary use of allergen advisory statements when appropriate. The chapter complements the FDA’s recently released Draft Compliance Policy Guide on Major Food Allergen Labeling and Cross-Contact, which reflects the agency’s risk-based and science-based approach for the evaluation of potential allergen violations.