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  1. FDA-TRACK: Agency-wide Program Performance

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 Rule) and “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals” (PC Animal Food Rule). 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 Rule

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 rule (CGMP & PCHF rule) 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 Rule Requirements

I. Adoption of Food Safety Plans by firms subject to the Preventive Controls requirements of the Current Good Manufacturing Practice and Preventive Controls rule for Human Foods

II. Preventive Controls Human Food Supply-Chain Program Requirements

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

IV. 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 Rule

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 rule

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

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


Outcome: Increased Compliance by Industry with Preventive Controls Rule Requirements

I. Adoption of Food Safety Plans by firms subject to the Preventive Controls requirements of the Current Good Manufacturing Practice and Preventive Controls rule for Human Foods

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II. Preventive Controls Human Food Supply-Chain Program Requirements

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

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IV. 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 Rule

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 rule

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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 rule

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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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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. In addition, FDA may change the type or amount of data provided on this website at any time.


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