FDA Releases Two New Chapters of Draft Guidance for the Preventive Controls for Human Food Rule

The US Food and Drug Administration (FDA) announced the availability of two new chapters to the Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food, designed to help food facilities comply with the preventive controls for human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 Chapter 11—Food Allergen Program and Chapter 16—Acidified Foods—are among the chapters that have been added since the draft guidance was first issued in 2016.

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. It 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. The chapter 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.

Chapter 16—Acidified Foods—applies to manufacturers of acidified foods (such as some processed sauces, beans, cucumbers, or cabbage that have an overall pH of 4.6 or below). It explains how these manufacturers can use procedures, practices, and processes that they have established to meet requirements in the acidified foods regulations and to meet requirements under the preventive controls for human foods rule.

Electronic comments can be submitted through the Federal eRulemaking Portal at Regulations.gov. Written comments should be sent to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All submissions received must include the Docket No. FDA-2016-D-2343 and should be submitted within 180 days to ensure the FDA receives comments before it begins work on the final versions of the guidance documents.

Additional Information

Notice of Availability: Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry

FDA Draft Guidance Could Result in Safer Food Options for People with Allergies to Sesame, Other Food Allergens

Food Safety Modernization Act (FSMA)

FSMA Final Rule for Preventive Controls for Human Food

FSMA Technical Assistance Network (TAN)