FDA-TRACK: Preventive Controls and Current Good Manufacturing Practice Measures
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.
Since mid-March 2020, FDA operations and FDA oversight of the U.S. food supply have been significantly impacted by the COVID-19 pandemic. The Agency's priorities during this time period have been the safety of our staff, conducting mission-critical activities, including inspections, responding to foodborne disease outbreaks, sampling and testing of imported food, and managing recalls. We have also worked to support continuity of the food supply chain, which includes keeping food and agricultural workers safe to allow continued production of food. Given these priorities, and state and local travel restrictions, FDA adjusted its approach to oversight activities.
For additional information, visit FDA's Food Safety and the Coronavirus Disease 2019 and FDA Efforts to Ensure Product Safety web pages.
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
III. Preventive Controls Human Food Supply-Chain Program Requirements
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
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.