Preventive Controls Rule

Preventive Controls Rule

The Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (Preventive Controls) final rule covers most facilities that manufacturer, process, pack, or hold food for consumption in the United States.  Covered facilities must establish and implement a food safety system that includes an analysis of hazards and risk-based preventive controls. The Preventive Controls final rule revises existing current good manufacturing practice (cGMP) regulations and requires that each facility develop and implement a written Food Safety Plan.

The Food Safety Plan must contain the following elements:

  1. an identification of known or reasonably foreseeable hazards  including: biological hazards, chemical (including radiological) hazards, physical hazards specific to each food at the facility,  and hazards that may be intentionally introduced for purposes of economic gain
  2. an evaluation of the hazards that includes an assessment of the severity of illness or injury if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls
  3. implementation of preventive controls for each hazard requiring a preventive control
  4. monitoring, corrective actions, and verification activities for each preventive control
  5. written supply-chain program for those ingredients the receiving facility has identified as a hazard requiring a supply-chain applied control
  6. the recall plan


Important Dates: Compliance dates are staggered based on facility size, and longer dates are set for the supply-chain program. For Compliance Periods go to the GMA Resources section below.

GMA Resources:

In-Depth Analysis of the Original Preventive Controls Proposed Rule

GMA Comments on the Original Preventive Controls Proposed  Rule:

GMA Comments on Preventive Controls for Human Food 11-22-2013 - Food Safety Plan.pdf
GMA Comments on Preventive Controls for Human Food 11-22-2013 - Testing.pdf
GMA Comments on Preventive Controls for Human Food 11-22-2013 - Good Manufacturing Practices.pdf
GMA Comments on Preventive Controls for Human Food 11-22-2013 - Records and Registration .pdf
GMA Comments on Preventive Controls for Human Food 11-22-2013 - Supplier Approval and Verification Program.pdf
GMA Comments on Preventive Controls for Human Food 11-22-2013 - Preliminary Regulatory Impact Analysis.pdf
GMA Comments on Preventive Controls for Human Food 11-22-2013 - Information Collection Burden.pdf
GMA Comments on Preventive Controls for Human Food 11-22-2013 - Reinspection Fee.pdf
OMB Redline-Deleted Supplier Verification Language
In-Depth Analysis of the Supplemental Preventive Controls Rule
GMA Comments on Economically Motivated Adulteration
FSMA Timeline and Milestones
GMA Reference Sheet for FSMA Compliance Dates
GMA Summary Reference Sheet for FSMA Compliance Dates
GMA Comments on the Supplemental Preventive Controls Rule
Hogan Lovells Memorandum

Links to FSMA Documents:

Full Text of the Original Preventive Controls Proposed Rule
Full Text of the Supplemental Preventive Controls Rule
Redlined Supplemental Preventive Controls Rule
Original Preventive Controls PRIA
Supplemental Preventive Controls PRIA 

Links to FDA Resources:

FDA’s Preventive Controls Rule page
Preventive Controls Rule Docket
Human Food Preventive Controls Final Rule


Contact Information: Warren Stone

Disclaimer: The materials on this website are provided for informational purposes only and do not constitute legal advice. GMA does not advise on the application of law to an individual’s or company’s specific circumstances.  Although we go to great lengths to make sure our information is accurate and useful, we recommend you consult a lawyer if you want professional assurance that our information, and your interpretation of it, is appropriate to your particular situation.