FDA-TRACK: Preventive Controls and Current Good Manufacturing Practice Measures
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The Food Safety and Modernization Act (FSMA) is transforming the nation’s food safety system by shifting the focus from responding to foodborne illness to preventing it. Congress enacted FSMA in response to dramatic changes in the global food system and in our understanding of foodborne illness and its consequences, including the realization that foodborne illness is both a significant public health problem and a threat to the economic well-being of the food system.
This set of measures focuses on the FSMA rules entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” (PC Human Food Regulation) and “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals” (PC Animal Food Regulation). The first compliance dates for these rules arrived in September 2016 for the largest businesses.
Outcome: Reduced Risk of Illness Attributed to Food From Facilities Subject to the Preventive Controls Regulations
FDA is collaborating with the Centers for Disease Control and Prevention (CDC) to establish methods to estimate the impact of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PCHF regulation) on foodborne illness in the United States. FDA and CDC continue to develop metrics for this outcome and will report measures once finalized.
Outcome: Increased Compliance by Industry with Preventive Controls Regulation Requirements
Outcome: More Rapid and Effective Recall Actions by Facilities Subject to the Preventive Controls Regulation
Outcome: Increased Compliance by Industry with Preventive Controls Regulation Requirements
I. Adoption of Food Safety Plans by firms subject to the Preventive Controls requirements of the Current Good Manufacturing Practice and Preventive Controls regulation for Human Foods
Note: Preliminary FY 2024 performance is presented in the charts below.
II. Adoption of Food Safety Plans by firms subject to the Preventive Controls requirements of the Current Good Manufacturing Practice and Preventive Controls regulation for Animal Foods
III. Preventive Controls Human Food Supply-Chain Program Requirements
Note: Preliminary FY 2024 performance is presented in the chart below.
IV. Number and Percent of Domestic Preventive Controls inspections classified NAI, VAI, OAI
V. Number and Percent of Animal Food CGMP inspections under 21 CFR part 507 classified NAI, VAI, OAI
Outcome: More Rapid and Effective Recall Actions by Facilities Subject to the Preventive Controls Regulation
I. Number of Class I and Class II recall events attributed to food produced at facilities subject to the Preventive Controls requirements of the CGMP & PC Human Food regulation
II. Number of Class I and Class II recall events attributed to food produced at facilities subject to the Preventive Controls Animal Food regulation
III. Time between recall initiation and firm issuance of initial press release to the public for Class I recalls
Download FDA-TRACK PC and CGMP Dataset
Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons.