FDA-TRACK: Preventive Controls and Current Good Manufacturing Practice Measures

 

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Relevant Links:

1. • Food Safety Modernization Act
2. • FSMA Final Rule for Preventive Controls for Human Food
3. • FSMA Final Rule for Preventive Controls for Animal Food

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.

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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

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

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

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

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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

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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

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III. Preventive Controls Human Food Supply-Chain Program Requirements

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IV. Number and Percent of Domestic Preventive Controls inspections classified NAI, VAI, OAI

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V. Number and Percent of Animal Food CGMP inspections under 21 CFR part 507 classified NAI, VAI, OAI

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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

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II. Number of Class I and Class II recall events attributed to food produced at facilities subject to the Preventive Controls Animal Food regulation

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III. Time between recall initiation and firm issuance of initial press release to the public for Class I recalls

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Download 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.