FDA Releases Two New Chapters of Draft Guidance for the Preventive Controls for Human Food Rule

September 28, 2023

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allergensLast week the U.S. Food and Drug Administration (FDA) announced the availability of two new chapters to the Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food, designed to help food facilities comply with the preventive controls for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 Chapter 11—Food Allergen Program and Chapter 16—Acidified Foods—are among the chapters that have been added since the draft guidance was first issued in 2016.  

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.